RECOGNIZING INNOVATION. BY DESIGN. MAY 2017 | www.FacilityOfTheYear.org
2017 ACHIEVERS OF MANUFACTURING EXCELLENCE CATEGORY WINNERS xcellence is more than an aspirational Abbott 7 value. For members of the pharmaceutical Operational Excellence Emanufacturing industry, excellence is a deeply embedded belief that drives a collective Bristol-Myers Squibb 11 desire to improve the lives of patients. It manifests daily in the actions of more than Facility Integration 5 million pharmaceutical manufacturing employees around the world, and the relief Cook Pharmica 15 it provides millions of patients in the form of Equipment Innovation John E. Bournas medicines and medical devices.
Eli Lilly and Company 19 As the representative of some 18,000 men and women working in this global industry, one of ISPE’s roles is to shine a light on the beacons Process Innovation of excellence in pharmaceutical manufacturing. From buildings to Facility of the Future systems to people, through our conference venues, publications, and award programs, we pay homage to the best and the brightest. Jazz Pharmaceuticals 23 Project Execution The FOYA program was created to celebrate six facets of manufacturing excellence: Project Execution, Facility Integration, Equipment Innovation, Sustainability, Process Innovation, and PT. Kalbio Global Medika 27 Operational Excellence. FOYA is also evolving to refl ect paradigm Honorable Mention shifts within the industry. And so in 2016 we added a new category to refl ect the efforts of members who are developing solutions for the Nephron Pharmaceuticals Facility of the Future. This strengthens the foundation of the FOYA Corporation 30 program—the belief that patients benefi t most when technology, Honorable Mention innovation, and quality combine to produce manufacturing excellence.
This same ability to adapt, to not be defi ned or limited by what was, Novartis and University 34 is present in the submissions of each FOYA category winner and of Pennsylvania honorable mention. We are proud to honor the eight winners who Honorable Mention not only share our commitment to innovation—they also advance pharmaceutical manufacturing technology by demonstrating creativity and excellence in facility design, construction, and operations. ADVERTISERS’ INDEX Reading through this year’s submissions was inspiring. Our winners AES Clean Technology 17, 36 are exceptional in their ability to defi ne problem statements and execute their solutions with distinction. Not only was culture the Nephron Pharmaceuticals cornerstone of several of the winning projects, many demonstrated Corporation Inside Front Cover the relationship between corporate quality culture and operational excellence. Hailing from the United States, Puerto Rico, Ireland, and PM Group Back Cover Indonesia, our 2017 winners also represent the diversity of thought that fuels intellectual discourse and debate, and fosters innovation. Rommelag 33
May 2017 | 1 ISPE is an association rooted in the tradition of collaboration and knowledge sharing. It is our reason for being, and the reason our members join. We provide members with opportunities not only to learn from one another, we also make it possible for them to shape Facility of the Year Awards 2017 that learning to further pharmaceutical manufacturing innovation.
KNOWLEDGE TRANSFER Any reproduction of the contents of this supplement Since the fi rst publication almost four decades ago, ISPE Guidance in whole or part is strictly forbidden without the written permission of ISPE. Views and conclusions Documents have played a fundamental role in that learning process. expressed in articles herein are those of the authors The collective knowledge of the pharmaceutical manufacturing and not necessarily those of the editorial staff , industry professionals who write them—on topics as diverse as offi cials, and Board of Directors of ISPE. biopharmaceutical process development and data integrity— encourages innovation, furthers technological advances, and ©2017 International Society for Pharmaceutical Engineering. The ISPE logo and Facility of the Year facilitates regulatory compliance. Hundreds of members have Awards are registered trademarks. collaborated, debated, and discussed to write Guidance Documents for their colleagues. They do it selfl essly, and with the humility that ISPE Headquarters makes the knowledge they share so well received by their peers. 7200 Wisconsin Ave., Suite 305 Bethesda, MD 20817, US Tel: +1-301-364-9201 Does this knowledge seep into the processes and mindsets that Fax: +1-240-204-6024 create award-winning FOYA submissions? Does it foster innovative thinking and imagination? I will leave that for you to judge as you ISPE Operations and Training Center read through this year’s winning submissions. What is certain, from 600 N. Westshore Blvd., Suite 900 ISPE’S perspective, is that FOYA projects are a testament to the role Tampa, Florida 33609, US Telephone +1-813-960-2105 innovation and excellence play in pharmaceutical manufacturing. Fax +1-813-264-2816 Cheers, then, to FOYA Category Winners Abbott (Operational [email protected] Excellence), Bristol-Myers Squibb (Facility Integration), Cook www.ISPE.org Pharmica (Equipment Innovation), Eli Lilly and Company (Process Innovation and Facility of the Future), Jazz Pharmaceuticals (Project Execution), and Honorable Mentions Nephron Pharmaceuticals Corporation, Novartis-Penn Center for Advanced Cellular Therapies, and PT. Kalbio Global Medika.
John E. Bournas ISPE CEO and President
2 | 2017 Facility of the Year Awards
2013 WINNER OVERALL Vaccines Novartis and Diagnostics Innovation Process Facility Culture Flu Cell Holly Springs, North Carolina, US Biogen Idec Integration Facility Manufacturing Volume Flexible RTP Project US North Carolina, Ltd. Roche mann–La Ho F. Execution Project Building TR&D Basel, Switzerland MedImmune Innovation Equipment Upgrade UK Automation Project England, UK Liverpool, Speke, Ltd. & Co., Merck Excellence Operational and Biologics Sterile Vaccine (VBSF) Project Ireland Carlow, County Inc. Morphotek, Sustainability Plant Pilot US Pennsylvania, Ambler, Fully Single Use mAB Fully Facility Production China City, Wuxi 2014 WINNER OVERALL Pharmaceuticals Ireland zer Pfi Excellence Operational Expansion NSI Capacity Dublin, Ireland Castle, Grange Boehringer Ingelheim KG Pharma GmbH & Co. Innovation Equipment 5 and Aseptic Area Line Facility Combi Germany Biberach, Ltd. mann–La Roche Ho F. Sustainability B250-Q2K Facility Switzerland Kaiseraugst, Inc. Therapeutics Grifols Execution Project North Fractionation Grifols Facility US North Carolina, Clayton, Pharma Services Patheon Biologics) DSM (formerly Innovation Process Future of the Biologics Plant Australia Brisbane, Pharmaceutical Penn Ltd. Services Integration Facility Contained PennDragon Project Facility Manufacturing UK South Wales, Tredegar, Apptec WuXi of China Pharmaceutical Mention Honorable Single Use mAB Fully Facility Production China City, Wuxi 2015 WINNER OVERALL China AstraZeneca Execution Project Supply Solid Market Dose Facility China Taizhou, Pharma, Inc. Astellas Innovation Equipment and Packaging Tube Project Labeling Equipment Ireland Kerry, GMbH Biologika IDT Integration Facility Biologics and Vaccines Facility Production Germany Dessau, Pharmalucence Pharmaceuticals Mention Honorable of New Construction Aseptic Filling Facility US Massachusetts, Billerica, 2016 WINNER OVERALL a Member of Genentech, Group the Roche Innovation Process Service to Return CCP2 US California, Vacaville, BioPharma Solutions Baxter Excellence Operational Solutions Oncology Expansion Manufacturing Germany Halle (Westfalen), LLC Ethicon, Sustainability Conservation San Lorenzo Strategy Rico Puerto San Lorenzo, AG Vaccines Janssen Execution Project in B81J ZEBOV Bern, Germany Inc. zer Pfi Innovation Equipment Continuous, PCMM: Portable, and Miniature Modular, US Connecticut, Groton, Bio Inc. Takara Integration Facility Gene and for Center Processing Cell Project Construction Shiga, Japan Kusatsu, Pharma Manufacturing Greater Co. Ltd Mention Honorable Facility New Thailand Bangkok, of Strathclyde, University CMAC Mention Honorable Centre & Innovation Technology Scotland Glasgow, Services, Pharmaceutical West Inc. Mention Honorable (RS) Ready-to-Sterilize Expansion US North Carolina, Kinston,
Novartis and University of and University Novartis Pennsylvania Mention Honorable for Center Novartis-Penn Therapies Cellular Advanced US Philadelphia, Pennsylvania, Nephron Pharmaceuticals Pharmaceuticals Nephron Corporation Mention Honorable SC Nephron South Carolina Columbia, West US Global Medika Kalbio PT. Mention Honorable Facility Biotech Indonesia Jakarta, Jazz Pharmaceuticals Jazz Pharmaceuticals Execution Project Rock Project Athlone Monksland, Ireland Roscommon, Co. Eli Lilly and Company Eli Lilly and Company and Innovation Process the Future of Facility Compression Direct Continuous Kits 2 and 3 Manufacturing Indianapolis, Indiana, US (CM2) Rico Puerto and Carolina, (CM3) Cook Pharmica Cook Innovation Equipment Filling Line Flexible Indiana, US Bloomington, Bristol-Myers Squibb Bristol-Myers Integration Facility Biologics Development Building and Clinical Building Manufacturing US Massachusetts, Devens, 2017 Abbott Excellence Operational Excellence—A Operational Approach Quality A New Ireland Longford,
FACILITY OF THE YEAR AWARDS Awards of the Year Facility 4 | 2017 13 YEARS OF INNOVATION May 2017 | 5 2017 May
2005 WINNER OVERALL A/S Nordisk Novo Plant Manufacturing New Denmark Hillerød, Inc. Alkermes, Square Brickyard Site Manufacturing US Massachusetts, Cambridge, Inc. Apotex, its Etobicoke, Expansion to Facility Manufacturing Ontario, Canada Manitoba, Winnipeg, Ltd. Company KOWA its to Addition New for Plant Manufacturing Solid Dosage Products Oral Japan Nagoya, Lundbeck Pharmaceuticals Ltd. Facility Manufacturing New at Seal Sands England, UK Middlesborough, 2006 WINNER OVERALL BioPharma Solutions Baxter and Syringe Phase IV Vial Filling Project US Indiana, Bloomington, AstraZeneca Project Laboratory Scale Large UK eld, England, Macclesfi Daiichi Asubio Ltd. Pharma Co., Project Bio Plant) NBP (New Japan Tokyo, Pharmaceutica Janssen Facility Area Small Volume Geel, Belgium Pharmaceuticals Wyeth Campus BioPharma Wyeth The Project Castle Grange at Dublin, Ireland Therapeutics Biolex Special Merit Recognition Phase II Facility Pittsboro Expansion Project US North Carolina, Pittsboro, 2007 WINNER OVERALL Genentech Execution Project US California, Oceanside, LLC Pharmica, Cook Integration Facility Indiana, US Bloomington, Shanghai Roche Limited Pharmaceuticals, Execution Project Excellence Regional Shanghai, China Pharmaceutical Taiyo Ltd. Co., Industry Innovation Equipment Japan City, Takayama Pharma-Fertigung Vetter KG GmbH & Co. Innovation Process Germany Ravensburg, 2008 WINNER OVERALL Manufacturing zer Pfi Deutschland GmbH Innovation Process Germany Illertissen, Boehringer Ingelheim KG Pharma GmbH & Co. Integration Facility Germany Biberach, Squibb Bristol-Myers Innovation Equipment US Jersey, New Brunswick, New GmbH Biologika IDT Excellence Operational Germany Dessau-Rosslau, AG mann-La Roche Ho F. Execution Project Basel, Switzerland Schaff hausen, Switzerland hausen, Schaff & Chemicals Orchid Pharmaceuticals Excellence Regional India Aurangabad, 2009 WINNER OVERALL Pharma Biotech Roche Basel Production Execution Project Basel, Switzerland Aseptic Technologies Innovation Equipment Gembloux, Belgium Biologics Ireland Centocor Sustainability Ireland Cork, Ringaskiddy, hausen Scha R&D Centocor Integration Facility Switzerland hausen, Schaff hameln Pharmaceuticals Limited Excellence Operational Hameln, Germany & Chemicals Orchid Pharmaceuticals Excellence Regional India Aurangabad, 2010 WINNER OVERALL Genentech Execution Project Singapore Tuas, Biogen Idec Excellence Operational US North Carolina, MannKind Corporation and Innovation Equipment Innovation Process US Connecticut, Ireland Biotechnology zer Pfi Sustainability Ireland Cork, County Pharmaceuticals Ireland zer Pfi Integration Facility Dublin, Ireland Honorable Mention Honorable Atlas Project Building 400 Facility US Massachusetts, Lexington, 2011 WINNER OVERALL LLC MedImmune, Execution Project Center Manufacturing Frederick Expansion Facility Maryland, US Frederick, Ltd. Roche mann–La Ho F. Innovation Process Supply Clinical “MyDose” Facility Switzerland Kaiseraugst, Inc. & Co., Merck Integration Facility Supplies Global Clinica and Packaging, Manufacturing, Expansion Project Warehouse US Jersey, Summit, New and Vaccines Novartis GmbH Diagnostics Innovation Equipment “MARS Project” Facility Site) (Marburg Germany Marburg, Health AB zer Pfi Excellence Operational – Bio 7 Pegasus Project Facility Manufacturing Sweden Strängnäs, Manufacturing zer Pfi Deutschland GmbH Sustainability Restructuring Plant Strategic Plan Project Master and Energy Germany Freiburg, HGT Shire Mention Honorable Atlas Project Building 400 Facility US Massachusetts, Lexington,
Dublin, Ireland Dublin, Ireland its New Greenfi eld Facility eld Greenfi its New Novel Collaboration for for Collaboration Novel Honorable Mention Honorable and Training (NIBRT) and Training Bioprocessing Research Research Bioprocessing National Institute for for Institute National Penzberg, Germany Penzberg, TP Expand Project Operational Excellence Operational Roche Diagnostics GmbH Diagnostics Roche Laupheim, Germany REX III Manufacturing Facility REX III Manufacturing Equipment Innovation Equipment Dublin, Ireland Dublin, Ireland Dublin, Ireland GmbH for Collaboration Novel Facility eld Greenfi its New Rentschler Biotechnologie Biotechnologie Rentschler (NIBRT) and Training Andhra Pradesh, India Pradesh, Andhra Research Bioprocessing Eisai Knowledge Centre Facility Centre Eisai Knowledge Project Execution Project Manufacturing Pvt. Ltd. Manufacturing Eisai Pharmatechnology & Eisai Pharmatechnology Parma, Italy Parma, Centre Facility Facility Centre Research and Development and Development Research Chiesi Farmaceutici Chiesi Farmaceutici Sustainability S.p.A. Chiesi Farmaceutici Durham, North Carolina, US Durham, North Carolina, Program of Projects Program Manufacturing Facility (VBF) Facility Manufacturing Merck Vaccine Bulk Vaccine Merck Facility Integration Integration Facility Merck & Co., Inc. & Co., Merck OVERALL WINNER OVERALL 2012 Photo: Yossi May, Washington Talent Washington May, Yossi Photo: - James Breen, FOYA Judging Committee Chair Judging Committee FOYA James Breen, , we all enjoy working within an in- working all enjoy , we ve led the FOYA Judging Committee for Judging Committee led the FOYA ve ould like to thank the FOYA judges for thank the FOYA to ould like his year we added a new category called category added a new we his year Finally T I ha I w the past five years and I have found it to be to found it a and I have years five the past - and pro personally both experience, wonderful these at of leaders a group Having fessionally. thein trends recent share to us allows sessions these learned from lessons discuss industry, communicate can we how and explore projects, ISPE mem- the entire across practices best these learned a I have the industry. advance to bership a technical from deal judging these projects great which of view, point management and project employer my for duties my perform to me allows the leveraging while efficiently and more better FOYA ISPE each believe I industry. in trends latest claim this same benefit. judge would - as the compa their time as well volunteering the final Selecting projects. submitted nies that year as the each difficult more gets awards increase. submissions of project quality our patients. of the lives improves that dustry must we industry, an as mission this continue To each day; our performance improve to strive of those the effort recognize us to allows FOYA ‹› do. that - prod in new transfer costs, reduce quality, prove technology information new or implement ucts, - pro these that understand judges The solutions. at of the business the success to critical are jects smaller on and award focus so we each facility, a good return. demonstrate that projects - devel was category The of the Future. Facility manufactur changing the to response in oped the application recognize to ing environment design of innovative implementation and/or and unique solu- technologies, new concepts, of generation the next exemplify tions that new and effective and efficient, flexible, agile, facilities. sciences life existing t the overall winner from from winner t the overall eas judges focus on is safety, on is safety, eas judges focus yth that I know all the judges would all the judges would I know yth that - number of catego a limited are hile there - and expe expertise collective he judges’ W One m One of the ar Judges then selec T like to dispel is that only large complex projects projects complex large only dispel is that to like from be farther could Nothing these awards. win review as they this the truth—the judges discuss im- to small projects are Most submissions. the and whether it was top of mind during project project during mind of top was it whether and the safety review carefully They execution. of “days in terms portion of the submissions - record total or transferred,” restricted away, of the tone and the general able injury rate, expe- the judges’ reflects This culture. safety record safety a strong with projects that rience performance. better will have in- process The winners. among the category followed of discussions, rounds several volves the winners Once ballots. a series of secret by to sworn the judges are been selected have win- the category ISPE announces until secrecy the ISPE at winner is revealed overall The ners. in the fall. Annual Meeting - recog to the right judges reserve ry winners, These Mentions. Honorable with projects nize overcame that projects clearly successful are execution, challenges in planning, significant and delivery. ensuingthe during bear to brought is rience have they Once and evaluations. discussions with compliance for each submission screened the judges use their requirements, the program Do the project: understand to experience broad - and schedule seem reason costs the proposed the articulate clearly team project Did the able? the for value and the business accomplishment paper? project the in outlined outcome overall and external internal their use judges also The information benchmark the project to networks achieved. were as stated outcomes and ensure - - - - e with their individual shortlistse with their individual
ince 2004, a group of 10 to 15 leaders 10 to of a group 2004, ince have industry, pharmaceutical the in submit judge the projects to met ted for Facility of the Year Awards. Awards. of the Year Facility for ted
t the initial committee meeting, the judges meeting, t the initial committee he judging season starts in January with ahe judging season starts A Judges arriv T INNOVATION Vice and Judging Committee FOYA Chair, James Breen, Pharmaceuticals Biologics Expansion, Janssen President/Lead, AND REWARDING REWARDING AND RECOGNIZING RECOGNIZING review each submission, discuss their individ- discuss each submission, review and category, ual merits within the submitted other for qualify could they whether consider - pro This portfolio. within the FOYA categories each to listening much dialogue, for allows cess whether and determining assessment judge’s judg- provides segment This is novel. the project trends, industry new discuss to es with a forum in the submissions. reflected are they and how
to according rated have they that projects of they While and capability. safety, schedule, cost, their anal- help them catalog to a template have use their expert to the freedom have they yses, each project. in reviewing judgment
one-day meeting to review the FOYA submis the FOYA review to meeting one-day ISPE in the fourth to submitted sions, which are Submissions year. of the preceding quarter - repre and world of the all corners from come medical, in the pharmaceutical, projects sent - one pro and biologic fields. Judges nominate do not If they awards. of the FOYA each for ject excellence demonstrates that project a identify will not they however, one category, in any year. that the category award These are leaders in owner organizations from from organizations in owner leaders are These small both representing of the world, all regions within the pharmaceutical companies and large ex all have They industries. device and medical
tensive experience in their fields—engineering, experience tensive inter have most and quality; manufacturing, or lived have Several responsibilities. national are They countries. outside their native worked and understand knowledgeable, experienced, the global landscape. S THE FOYA JUDGING PROCESS Awards of the Year Facility 6 | 2017 FOYA 2017—OPERATIONAL EXCELLENCE May 2017 | 7 2017 May Project mission Project culture improvement continuous a sustainable Create area campus Total sq. ft. 135,000 Facility: 5,300 sq. ft. cations: modifi facility Internal ABBOTT diagnostics, products—in breakthrough Abbott creates generic and branded nutrition, medical devices, and your family, your help you, pharmaceuticals—that possibilities. of unlimited full lives, lead healthier community e ellenc c Y WINNERY WINNER tional Ex a TEGORTEGORTEGORTEGOR CACACA Oper Location Location Ireland Longford, Project Project New Excellence—A Operational Quality Approach “The Abbott Longford site site Abbott Longford “The productivity, has increased changeover improved efficiencies, eliminated and enhanced backorders, also quality—while product per unit, cycle cost reducing times, equipment downtime, holdings.” and inventory SECTION TITLE
CULTURAL SHIFT BEGETS WIDESPREAD IMPROVEMENT
hen the Abbott Diagnostics was looking to develop a sustainable growth one developed by the Shingo Institute, located facility in Longford, Ireland, strategy. It launched its operational excellence at the Jon M. Huntsman School of Business at launched its project in 2012, project with a view to building performance Utah State University. “That is when we really Wits goal was to create a sus- from the ground up. “This project is focused bolted the Shingo part onto our behaviors, be- tainable, continuous improvement culture that on creating a culture of long-term sustainable cause they both sat very well together,” says would deliver high-quality, safe, and effective performance,” says Everett Tucker, Division Corcoran. diagnostic products. Five years later, the facility Vice President, Global Operations Strategy and The Shingo Model is not an additional program has generated millions of dollars in cost savings, Engineering, Diagnostic Division at Abbott. “It or initiative that an organization integrates into product lead times have improved, inventories was about how we might create an environment its operations; according to the shingoprize.org and energy consumption have been reduced, where people are more empowered and more website, it is a set of 10 guiding principles that and employee morale has risen. The Longford involved in how the business runs.” are meant to anchor an organization’s current facility may also have created a model project Management conducted benchmarking of initiatives and to fill the gaps in its efforts to- that it can deploy at Abbott’s other facilities other organizations, including a visit to another wards ideal results and enterprise excellence. worldwide. manufacturing company. “The company had a Each principle plays a critical role in enabling model that was based around behaviors in the an organization’s culture, designing systems for BEHAVIOR-FOCUSED MODEL factory, and it drove a lot of operational excel- continuous improvement, aligning principles, The 135,000-sq.-ft. Longford facility was estab- lence behavior and activities at the company behaviors, and results across the enterprise, and lished in 2004 and currently employs more than site,” says Ciaran Corcoran, Site Director at the achieving a sustainable culture of excellence. 350 people involved in the design, development, Longford facility. “That got us thinking that we and manufacturing of in-vitro diagnostic prod- didn’t use this approach at our facility, and so we PEOPLE LINKED TO ucts. The company’s product portfolio includes took action to build the ‘Longford behaviors’ and STRATEGY diagnostic reagents for the detection of thyroid, what are we doing around those.” To avoid confusing employees by the introduc- fertility/pregnancy, cardiology, renal, and meta- Following further discussion and benchmark- tion of new “Shingo behaviors,” much effort was bolic markers. ing, Abbott Diagnostics’ management team spent identifying and connecting existing Ab- By 2012, the site had gone through its initial reached the conclusion that the operational ex- bott behavioral expectations to the Shingo prin- start-up phase and management at the facility cellence model it wanted to follow was based on ciples. In fact, the Longford behavioral standards
8 | 2017 Facility of the Year Awards ABBOTT OPERATIONAL EXCELLENCE are well aligned with the Shingo dimensions “BY WALKING AROUND AND MEETING of operational excellence as they specify that everyone in the organization needs to respect- PEOPLE IN THIS WAY, YOU ARE fully work together to deliver customer-focused REALLY SHOWING EVERYBODY HOW results while finding ways to improve. The site‘s functional departments develop ENGAGED THE MANAGEMENT TEAM their own local vision and strategy maps/bal- IS. AND IT ENABLES US TO MAKE anced scorecards by aligning their goals to the site strategy. Departmental goals are formally FAST DECISIONS.” agreed on an annual basis and cascaded through the organization. All departments contribute to site initiatives and develop their own depart- level load or how we can move things around. addition, the site has significantly reduced its ment-level initiatives that support the attain- And we start those conversations months ahead carbon footprint by consuming less energy (en- ment of their goals. The departmental strategy of time.” ergy usage fell by 23% between 2012 and 2015 maps/balanced scorecards form the basis for despite test-volume growth), eliminating waste visual management and give employees a clear AWARD-WINNING RESULTS going to landfill, and creating an on-site biodi- line of sight into how their jobs are linked to Through its Operational Excellence project, the versity garden. both site and departmental strategy, enabling Longford facility has achieved cost savings to- Employee morale at the site is high, and re- them to work in a coordinated and collaborative taling more than $13 million across all spending flected in its excellent employee attendance fashion. areas. These savings were generated by the re- record of at least 98%. Internal promotion rates “We are providing an ecosystem for employ- duced use of raw materials, lower energy con- are also high, attesting to the success of career ees to reach their full potential,” says Corcoran. sumption, automation, batch-size optimization, mentoring and coaching programs. Further- “People can very easily see a long-term career for and multiple process-improvement projects tar- more, creating an awareness of the benefits of themselves in the business and they know what’s geting the complete value chain. Furthermore, physical activity encourages all employees to going on in the business because the whole thing lead times have fallen by 38%, back orders have become more active, and the site provides a is very visual, open, and transparent.” been eliminated and there has been a 15% re- supportive workplace environment for doing so. Corcoran feels that the openness and trans- duction in distressed inventory. Corporate social responsibility (CSR) is also a parency enable him and his management team As of November 2016, the facility had accu- key focus of the Longford site. Employees volun- to anticipate risks. “We walk around the factory mulated 3,755 lost time accident-free days. In teer a combined total of more than 2,000 hours twice a week for about an hour and a half each time, and we go through various work centers all over the factory,” he says. “The employees have visual boards, they talk about their metrics, about their achievements, and their challenges. By walking around and meeting people in this way, you are really showing everybody how en- gaged the management team is. And it enables us to make fast decisions: if there are any risks to the business then I have an ability to quickly identify and address them. The whole system is built around transparency and openness, and that enables us to see risks ahead of time and do something about them.” In illustrating his point, Corcoran describes how the company has placed demand and ca- pacity visuals throughout the facility. Each de- partment tracks the demand placed upon it over a period, and then plots it on a chart. “You can see the demand and capacity on a simple chart that we look at every week,” he says. “Then, if we know that a project is coming in the next few months, we can ask the department if they can handle it. So, that drives anticipation and encour- ages different conversations about how we can
May 2017 | 9 ABBOTT OPERATIONAL EXCELLENCE
KEY PROJECT PARTICIPANTS MANUFACTURER /OWNER Abbott Ireland Diagnostics Lisnamuck Co. Longford, Ireland
ENGINEER/ARCHITECT (A&E) Agility/EM3 Business Centre Main Street Charleville Co. Cork, Ireland
ENGINEER/ARCHITECT (A&E); Rockwell Engineering CONSTRUCTION MANAGER; Millstreet Rd. MAIN/GENERAL CONTRACTOR; Macroom PIPING CONTRACTOR; Co. Cork, Ireland HVAC SUBCONTRACTOR AUTOMATION AND Nicotra Gebhardt GmbH CONTROL SUPPLIER Gebhardtstrasse 19-25 74638 Waldenburg, Germany
ELECTRICAL CONTRACTOR Frank McGowan & Sons Limited 15 Arcadia Court Athlone Co. Westmeath, Ireland CIVIL CONTRACTOR James Irwin Construction Ltd each year to the site’s many CSR initiatives. The site has offered several Unit 9 Dome Court Roscommon workshops on operational excellence for staff of hospitals that use Abbott Co. Roscommon, Ireland products and who are trying to introduce or reinforce lean principles. MAJOR EQUIPMENT SUPPLIERS Bausch Germany GmbH For its efforts, Abbott’s Longford facility has been recognized in Ireland Döllschützer Str. 1 and internationally, winning numerous awards, including the: D-07607 Hainspitz, Germany 2013 and 2014 Plant of the Year Award, from Abbott Global Pago Etikettiersysteme GmbH Environment, Health Safety & Energy Gutenbergstrasse 9 2015 Medtech Company of the Year Award, from the Irish Medtech DE-72631 Aichtal-Aich, Germany Association BBK Etikettier-und Sondermaschinenbau GmbH 2015 National Business Excellence Award, from the Irish Centre for Dieselstrasse 18 Business Excellence D-64743 Beerfelden, Germany 2015 Shingo Prize, from The Shingo Institute at the Jon M. Huntsman Portakabin School of Business, Utah State University Rosevill Business Park Special award for Behavioral Excellence for Safety, from the Shingo Turvey Ave. Institute, presented to Abbott Diagnostics Longford at the Shingo Donabate Co. Dublin, Ireland Awards ceremony in April 2016 Lift Rite Ltd. Abbott Diagnostic Longford’s operational excellence culture has become so Unit F1 Maynooth Business Campus well-entrenched that even the Shingo Institute’s review committee was im- Maynooth pressed. “They were impressed with the whole attitude in the facility, that the Co. Kildare, Ireland culture was so alive,” says Corcoran. Telstar Technologies, SL According to Everett Tucker, the key to the success of the company’s op- Av/ Font i Sagué, 55 erational excellence program is that it “wasn’t mandated or forced. It was an Parc Científici empowering, ground-up program that really stimulated and excited people. Tecnològic Orbital 40 08227 Terrassa It isn’t something that will simply die of its own weight once there is a change Barcelona, Spain in leadership. And because of the progress that we made in Longford, we are looking to replicate this model at our other sites as well.” ‹› RTD Technology Ltd., T/A Asistec Unit 15A, Solus Tower Estate Corke Abbey Bray Co. Wicklow, Ireland
Astra Clean Systems/Lighting Kingsway House 23A Marlborough Rd. Lancing, West Sussex, England BN15 8TR
10 | 2017 Facility of the Year Awards FOYA 2017—FACILITY INTEGRATION May 2017 | 11 2017 May Project mission Project a next-generation Squibb into Bristol-Myers Transition companybiopharmaceutical area campus Total acres 89 BRISTOL-MYERS BRISTOL-MYERS SQUIBB company biopharmaceutical Squibb is a global Bristol-Myers innovative and deliver develop, discover, is to whose mission serious diseases. over prevail help patients medicines that tion a egr Y WINNERY WINNER TEGORTEGORTEGORTEGOR acility Int F CACACA Location US Massachusetts, Devens, Project Project Building Biologics Development and Clinical Manufacturing Building “Modifications to the the to “Modifications campus—additions existing utilities, parking the to and CUB, pipe rack, garage, management— storm water focus a deliberate required and integration. on planning impressive, were results The of this and the integration broader within BMS’s facility of and network mission made this submission assets out.” stand SECTION TITLE
FLEXIBILITY AND COLLABORATION ANCHOR EXPANSION
dding a new facility to an existing warehouse, and a three-story parking garage. lease Corporation was given the overall con- campus is always a complex task, The second phase, a $280-million expansion struction mandate. requiring advanced planning, ad- aimed at accelerating the development and As the designs for each building took shape Ajustment to inevitable challenges, launch of innovative new medicines, was com- over the following months, the BMS team decid- and exceptional collaboration among design- pleted in January 2016. It added two physically ed that the two facilities should be built in par- ers, scientists, construction crews, and teams connected buildings: the 230,000-square-foot allel. This posed a challenge: how to construct from existing facilities. Global biopharmaceuti- four-story BDB and the 131,000-square-foot two separate facilities, designed by two sepa- cal company Bristol-Myers Squibb (BMS) took multistory CMB. rate architects and built by a single construction things to another level when it combined two “Devens is one of our primary biologics pro- manager, on a fully operational campus? It be- separate construction projects at its Devens, duction sites,” says Bryan Mann, Director, Capital came apparent as well that the new construction Massachusetts, campus: adding a biologics de- Projects at BMS. “The driver was to build a de- would require several modifications to the exist- velopment building (BDB) and a clinical manu- velopment facility and a clinical manufacturing ing campus, including additions to the utilities, facturing building (CMB), all with minimal dis- facility that would centrally integrate everything, parking garage, CUB, and pipe rack and storm ruption to existing facilities. from research all the way to production, and water management facilities. Located 45 miles west of Boston, the Devens have all of those key items on the same site.” Needless to say, a high level of collaboration site is an 89-acre biologics campus that BMS is and coordination, along with innovative delivery developing according to a multiphase master KEEPING ALL INFORMED methods, were required to execute the project. plan. The initial phase, budgeted at $750 million, BMS began planning for the expansion of the “Between the A&E teams, BMS, and Lendlease, was completed between 2007 and 2009. It in- Devens campus in early 2013. Architect and there was a lot of preplanning involved,” says cluded the construction of a large-scale cell-cul- Engineering (A&E) contracts were awarded for Daniel Post, Associate Director–Technical Ser- ture building, a lab/office/cafeteria building, a each building, with ARC/Architectural Resources vices, Engineering at BMS, who acted as project central-utilities building (CUB), a wastewater Cambridge responsible for the BDB, and Clark, manager for the BDB. “We had to review which treatment plant, a cryogenic storage building, a Richardson & Biskup (CRB) for the CMB. Lend- utilities had to be tied into the new buildings, and
12 | 2017 Facility of the Year Awards BRISTOL-MYERS SQUIBB FACILITY INTEGRATION
would therefore be affected by construction, and tions and site personnel. Planning was the key The central utilities pipe rack had to be de- we were able to segregate the new area from the to success, and we have continued to use this signed for two different buildings with two rest of the site with fencing and good logistics.” process on other projects.” different needs, which required extensive co- “During the preconstruction period we spent ordination between the engineering teams. In a lot of time planning to make sure that we could OVERCOMING CHALLENGES addition, electrical conduit had to be looped avoid impeding operations at the existing facil- Groundbreaking at the site took place in Febru- through both buildings and reconnected back ity and separate the construction zone from the ary 2014. One year later, while the roof was in to an existing building so each facility could be rest of the campus,” says Scott Tereshak, Project place, an unusually snowy winter saw close to served from two directions as well as allow for Executive for Lendlease. “With the help of the 10 feet of snow fall over a six-week period. Con- redundancy and future expansion. This required design teams, we also planned out where BMS struction crews spent many days shoveling snow well-planned system shutdowns in addition to intended to schedule shutdowns so we could instead of building the facilities. determining how to tie in to the electrical system coordinate the project schedule around them.” The project team also faced several challenges without interrupting existing operations. Furthermore, the team developed a process unique to the simultaneous construction of two The project was completed on schedule and to keep everyone on the site informed of up- new facilities. A&E firms CRB and ARC collab- within budget, nonetheless. “The BDB was ready coming activities. “We developed a ‘construction orated to design a shared waste-processing for occupation in November 2015,” says Post. activities notice’ process,” explains CMB project system for both buildings, which saved time “Staff moved in within a month, and two weeks manager Anthony Haskell, Associate Director, and money. The process created an additional from the initial move-in some groups were set Project Manager at BMS. “Any activities related challenge, however, because the underground up and doing science. The CMB staff moved in to the site followed this notification process; the portion of the system had to be installed before early 2016 as qualification was winding down completed form went out for review by all stake- the slabs were poured for the BDB and CMB. Ad- and engineering runs were starting. Beneficial holders. We held weekly meetings to review and ditionally, volume/capacity calculations for the use was realized in April 2016.” coordinate this type of work with the site team. CMB had to be done before the process line had From all accounts employees working at The goal was to minimize the impact to opera- been fully engineered. the new facilities are exhilarated by the results.
May 2017 | 13 BRISTOL-MYERS SQUIBB FACILITY INTEGRATION
“ONE OF THE THINGS KEY PROJECT PARTICIPANTS MANUFACTURER/OWNER Bristol-Myers Squibb WE DON’T WANT TO 38 Jackson Rd. LOSE SIGHT OF IS Devens, Massachusetts 01434 United States ENGINEER/ARCHITECT (A&E) ARC/Architectural Resources Cambridge THE INTEGRATION OF 501 Boylston St., Suite 4101 POTENTIAL NEW MEDICINES Boston, Massachusetts 02116 United States Clark, Richardson & Biskup (CRB) THROUGH COMMERCIAL 220 West Germantown Pike, Suite 170 MANUFACTURING TO GET Plymouth Meeting, Pennsylvania 19462 United States CONSTRUCTION MANAGER Lendlease (US) Construction LMB Inc. THE MEDICATIONS TO 20 City Square, 2nd Floor THE PATIENT.” Boston, Massachusetts 02129 United States STRUCTURAL ENGINEERS Symmes Maini & McKee Associates (SMMA) 1000 Massachusetts Ave. “When we were all there for the ribbon-cutting and we walked around with Cambridge, Massachusetts 02138 United States the scientists, there was palpable excitement,” says Tereshak. “Employees SNC-Lavalin Project Services, Inc. knew how important it was for them to interact with the other people in 436 Creamery Way #100 the chain, going from process development all the way through commercial Exton, Pennsylvania 19341 United States production.” MAJOR EQUIPMENT SUPPLIER GE Healthcare Reflecting on the successful project, Jeffreys Johnson, AIA, Principal in 3350 North Ridge Ave. Charge at ARC, points to the collaboration between all the companies in- Arlington Heights, Illinois 60004 United States volved. “We saw a lot of challenges, but if we hadn’t worked together so SITE VHB closely and so well the challenges would have been much greater,” he says. 99 High St., 10th Floor “But it was a very collaborative process from the start, and that really did Boston, Massachusetts 02110 United States make it the successful project that it is.” Ryan McDonough, Senior Associate, Biotechnology Core Team Leader at CRB, sums up the project this way: “The CMB is one of a small number of fully single-use manufacturing facilities in this industry. And one of the things that we don’t want to lose sight of is the integration of discovery of potential new medicines through commercial manufacturing to get the medications to the patient. Having that all on one campus is pretty important.” ‹›
14 | 2017 Facility of the Year Awards FOYA 2017—EQUIPMENT INNOVATION
COOK PHARMICA
Located in Bloomington, Indiana, Cook Pharmica is a privately held CDMO that provides biopharmaceutical companies with a unique one-source, one-location model for development, clinical, or commercial cell culture CATEGORY WINNER Equipment Innovation manufacturing, parenteral product manufacturing and secondary packaging.
“This unique collaboration between owner, suppliers, and engineering experts delivered a novel application of commercially available and custom-developed equipment innovation that drove superior commercial, market-changing technology, and supply chain flexibility on a “ready-to-use” vial platform.”
Project Project mission Flexible Filling Line Leverage new technologies to add fl exibility and capacity within an existing cGMP space Location Bloomington, Indiana, US Total campus area 2,300 sq. ft.
May 2017 | 15 INNOVATION AND INFLUENCE
INNOVATION AND INFLUENCE
lexibility is a critical attribute for any dent and Chief Operating Officer. SMOOTH DEPLOYMENT successful contract development and The concept for Cook Pharmica’s flexible fill- Within 12 months of its official kickoff meeting in manufacturing organization (CDMO). ing line began in 2010. “Over the next five years,” October 2014, Cook’s FFL project staff began fac- FIt can manifest itself in the ability says Hawkins, “things changed in the supply of tory acceptance testing for the flexible filling line, to manufacture a wide variety of medicines or ready-to-use vials and cartridges, as well as with including the lyophilizer, isolator, and fill line. to rapidly accommodate new client requests. robotic technology. The changes helped create Cook had available cleanroom space adjacent Cook Pharmica’s recently completed Flexible more possibilities vs challenges associated with to its existing filling operations, and to mitigate Filling Line (FFL) project enables the company processing multiple formats on a single line.” any disruptions to the site, Hawkins’s team co- to achieve all this, along with the ability to man- Cook pursued the development of its concept ordinated with suppliers to have the equipment ufacture vials, syringes, and cartridges from a with two trusted partners, OPTIMA Pharma, the installed during the plant’s annual shutdown pe- single filling line. worldwide leader in packaging technologies, in- riod in December 2015. Seeing strong market acceptance of its exist- cluding biopharmaceutical filling and packaging, “We built this line to be a clinical workhorse, ing vial and syringe product lines, and conscious and Nuova Ompi, a global producer of primary but we also intended it to be commercially capa- of a shift in the industry to extend the ready-to- glass packaging for the pharmaceutical indus- ble. We are already doing engineering batches use platform and utilize new capabilities for fill- try. By combining its product development and for clients, and we have a number of projects ing flexibility, Cook began planning to combine manufacturing knowledge with the expertise of lined up, including the process performance activities associated with what had traditionally a machine builder and a component supplier, qualification protocol, which is the last stage be- been three filling lines into one line under barrier Cook created a strong partnership to expand its fore commercialization.” isolation, in one filling suite. current capability. “With every filled unit representing a patient, “This partnership was about working togeth- ADVANCED TECHNOLOGY we are excited about this capability and capacity er, with a common goal of making a version of OPTIMA Pharma’s flexible filler is a first-of-its- to help our clients reach millions more patients,” flexible filling that would benefit each company kind solution, capable of filling syringes (up to says Ryan Hawkins, Cook Pharmica’s Vice Presi- and possibly, the industry,” says Hawkins. 5 ml), vials (up to 30 ml) and cartridges (up to 3 ml). The FFL handles all components in a nested
16 | 2017 Facility of the Year Awards COOK PHARMICA EQUIPMENT INNOVATION
format, as well as vials in tray format, a newly available solution from Nuova Ompi. The line offers further flexibility by dosing via peristaltic pumps and a single-use disposable (SUD) product path or via time-pressure dosing steam-in-place capability. Automated in-process check weighing and other advanced features en- sure accurate dosing and minimal rejects. A 72-sq.-ft. freeze dryer coupled to the line enables manufacture of lyophilized products. The vial capper on the line serves both the new flexible filler and capping product from the adjacent commercial vial line. The FFL uses barrier isolation technology to provide the highest level of aseptic processing. This includes new catalytic aeration technology that en- ables short bio-decontamination cycle times, which levels changeover times compared to lines that do not have automated decontamination. No-touch transfers and handling are facilitated through automation of component tub/ tray de-bagging and de-lidding. In addition, robotic denesting/detraying, as well as automated lyophilizer loading and unloading, ensure simple and re- peatable transitions and eliminate built-in operator involvement.
STRATEGIC AND INNOVATIVE For Cook, the new FFL is a strategic enabler that allows the company to expand its manufacturing capabilities and support increased volumes of
May 2017 | 17 COOK PHARMICA EQUIPMENT INNOVATION
“AS A CDMO, WE MAY KEY PROJECT PARTICIPANTS MANUFACTURER/OWNER Cook Pharmica NOT HAVE OUR OWN 1300 S. Patterson Dr. PRODUCTS, YET THAT Bloomington, Indiana 47403 United States ENGINEER/ARCHITECT (A&E) IPS-Integrated Project Services, LLC DOESN’T MEAN WE CAN’T 721 Arbor Way Suite 100 INNOVATE OR INFLUENCE Blue Bell, Pennsylvania 19422 United States INDUSTRY.” Plymouth Meeting, Pennsylvania 19462 United States CONSTRUCTION MANAGER Commissioning Agents, Inc. 652 N. Girls School Rd. Indianapolis, Indiana 46214 United States specialized products within its cGMP offering. The ability to process multi- HVAC SUBCONTRACTOR Poynter Sheet Metal ple configurations and formats results in a more cost-effective method of 775 Commerce Pkwy W. Dr. delivering value to customers and end users. Greenwood, Indiana 46143 United States “With the addition of this line, we can now do capping on the FFL for MAJOR EQUIPMENT SUPPLIER Optima pharma GmbH anything that is liquid or lyophilized on our current vial line. It provides us Otto-Hahn-Strasse 1 flexibility in terms of format, capacity, and scheduling,” says Hawkins. 74523 Schwaebisch Hall, Germany In reflecting on the project, Hawkins proudly notes its innovative nature. PROCESS ENGINEER Core-Reliance 991 U.S. Highway 22 W. “It is not always easy to innovate in biopharma,” he says. “I would like to Ste. 200 think our new platform could be a leading standard or part of a broader Bridgewater, New Jersey 08807 United States shift in industry. As a CDMO, we may not have our own products, yet that CIVIL/ARCHITECTURAL Fox Construction doesn’t mean we can’t innovate or influence industry.”‹› CONTRACTOR 207 W. 10th St. Bloomington, Indiana 47404 United States
MECHANICAL CONTRACTOR HFI 2010 Vernal Pike Bloomington, Indiana 47402 United States HVAC AUTOMATION Thermo Systems CONTRACTOR 84 Twin Rivers Dr. East Windsor, New Jersey 08520 United States ELECTRICAL CONTRACTOR Cassady Electrical Contractors 2200 W. Tapp Rd. Bloomington, Indiana 47403 United States MODULAR/CLEAN ROOM AES Clean Technologies, Inc. CONTRACTOR 422 Stump Rd. Montgomeryville, Pennsylvania 18936 United States EQUIPMENT MOVE-IN Cardinal Contracting CONTRACTOR 2300 South Tibbs Ave. Indianapolis, Indiana 46241 United States
ROOFING CONTRACTOR Building Associates Inc. 3701 Jonathan Dr. Bloomington, Indiana 47404 United States
FLOORING CONTRACTOR Cornerstone Flooring St. Patrick Drive Brownsburg, Indiana 46112 United States
FABRICATION/STEEL SETTING Wilhelm Construction CONTRACTOR 3914 Prospect St. Indianapolis, Indiana 46203 United States INSULATION CONTRACTOR Gribbins Insulation 821 W. Johnson Dr. Terre Haute, Indiana 47802 United States FIRE PROTECTION Ryan Fire Protection CONTRACTOR 9740 E. 148th St. Noblesville, Indiana 46060 United States TELECOMMUNICATIONS Indiana Voice and Data CONTRACTOR 840 W. 17th St., #6. Bloomington, Indiana 47404 United States
18 | 2017 Facility of the Year Awards FOYA 2017—PROCESS INNOVATION AND FACILITY OF THE FUTURE May 2017 | 19 2017 May Project mission Project continuous of state-of-the-art Design and implement a network and commercialization for facilities process manufacturing of tablets production facility) in existing with project (associated oor area fl facility Total sq. ft. CM2: 4,975 sq. ft. CM3: 4,720 ELI LILLY AND LILLY ELI COMPANY unites leader that is a global health care Eli Lilly and Company around people for better life make to caring with discovery a man ago by a century than more founded It was the world. meet real high-quality medicines that creating to committed in all its work. mission that true to remains needs, and today e tion va Y WINNERY WINNER Y WINNERY WINNER ess Inno TEGORTEGORTEGORTEGOR TEGORTEGORTEGORTEGOR oc acility of the Futur Pr CACACA CACACA F Location Indianapolis, Indiana, US (CM2) (CM3) Rico Puerto and Carolina, Project Compression Direct Continuous Kits 2 and 3 Manufacturing “Lilly was also named also named “Lilly was winner of the FOYA of the Future Facility their process for category production development, commitment, platform of three and deployment operational replicate production OSD continuous facilities.” “Eli Lilly and Company “Eli Lilly and Company of named winner was Process 2017 the FOYA for Award Innovation their forward-thinking of implementation direct continuous and (CDC) compression innovations other process solid dose (OSD) in oral their across facilities network. manufacturing SECTION TITLE
CONTINUOUS INNOVATIVE THINKING WINS TWICE
ontinuous manufacturing (CM), one tial project, known as CM1, was completed at the Integration was a central principle that influ- of the newest and most advanced company’s development facilities in Indianapolis, enced all aspects of the project. At the system production methods, is a hot topic Indiana, US. level, feeding, mixing, and tablet compression unit Cin the pharmaceutical industry. For “The first thing you notice is that CM speeds operations are seamlessly integrated with online companies able to develop a reliable process, up the development cycle on new products,” PAT and first-principles modeling to provide a CM’s benefits can include reduced costs, im- says David Sternasty, Vice President, Corporate comprehensive unified control strategy. The Lilly proved speed, and better quality control. Engineering, Global Health, Safety, and Envi- CM platform also relies on integration at the indi- Global health care leader Eli Lilly and Com- ronmental at Lilly. “Under an older production vidual unit operational level. pany considers itself on the leading edge in its model, a development scientist might make 16 The company designed a novel approach for use of this technology. As part of its recently or 32 discrete batches of product in a designed its dispensing and feeding unit. Lilly’s process is completed CM project, the company developed experiment that then have to be lab tested to innovative because feeders are actively controlled a CDC manufacturing process that it then de- determine how process parameters impact pro- as an integrated system rather than a series of in- ployed in two additional facilities. duction. In a continuous processing unit, param- dependent set points using a cascade control loop, About five years ago, Lilly began to consider eters are established by adjusting controls and, also known as ratio control. By designating a mas- the possibility of implementing CM for its oral consequently, you can do multiple experiments ter feeder (typically the drug substance feeder) solid dosage (OSD) products. The company’s de- very quickly. This is a huge advantage for de- and modulating the other feeders in response to velopment group began to work with the tech- velopment scientists, because it allows them to variation in the master feeder output, the concen- nology, investing time and energy to ensure that gain product understanding quickly. This was tration of formulation components is maintained it fully understood CM and its potential benefits the reason, from a development standpoint, that more consistently. The powder feeder feedback and integrating PAT into the initiative. That ini- we originally started moving to CM.” control loops automatically adjust for raw material
20 | 2017 Facility of the Year Awards ELI LILLY AND COMPANY PROCESS INNOVATION FACILITY OF THE FUTURE
ified in only 11 months and placed into service. “Because of the efficiencies, and the fact we were replicating an installation we had just completed,” says Pletcher, “we were able to reuse and leverage commissioning and qualification protocols as well as much of the design work. This approach has proved to be a very efficient and effective way to replicate units from one facility to another.” Both CM2 and CM3 are functional repli- cates with identical equipment, layout, PAT instrumentation, and automation and control schemes. According to Sternasty, the design of both GMP equipment sets benefited from years of optimization and evolution work on the pro- totype CM1 installation. “We have seen that a benefit with the CM
changes such as density and powder flow. Additionally, the CM1 development unit taught the Lilly team learned to deal with other variables, such as environmental disturbances, vibration, and room-pressure changes. “These feeders are incredibly sensitive, and they are on very sensitive scales,” explains Timothy Pletch- er, Lilly’s Associate Senior Consultant Engineer. “We learned that we needed to be mindful and design a system that could provide as much sta- bility as possible. So we worked closely with our A&E [architecture and engineering] firm to de- sign structurally independent platforms, such as on the midlevel feeders and upper-level feeders, which were mass-dampened to give us as much stability as we could achieve.”
EFFICIENT REPLICATION In September 2014 Lilly determined that the CM1 platform was ready for use in a commer- cial manufacturing environment. The company launched the CM2 project, which it planned to integrate into the company’s existing OSD facil- ity in Indianapolis. Building on lessons learned in the development phase, the CM2 line pro- gressed quickly through construction, commis- sioning, and qualification; the unit was ready for production of three development molecules, in line with good manufacturing practice (GMP), in November 2015. A mere 15 months had elapsed between the company’s funding approval and its ability to produce commercial products destined for patients. Installation of a second GMP unit (CM3) at an OSD manufacturing facility in Carolina, Puerto Rico, began in November 2015. The unit was qual-
May 2017 | 21 ELI LILLY AND COMPANY PROCESS INNOVATION FACILITY OF THE FUTURE
“CONTINUOUS MANUFACTURING IS AN INNOVATIVE WAY TO PROVIDE A RELIABLE, SAFE SUPPLY OF HIGH-QUALITY MEDICINES, AND BRING OUR PRODUCT THROUGH THE PIPELINE AS QUICKLY AS WE CAN.” KEY PROJECT PARTICIPANTS MANUFACTURER/ Eli Lilly and Company Lilly del Caribe OWNER Lilly Corporate Center PO Box 1198 Indianapolis, Indiana 46285 Carolina, Puerto Rico process is that there is no scale-up,” says Sternasty. “Because we are using United States 00986-1198 continuously running equipment that is very small in scope, the equipment ENGINEER/ Mussett Nicholas & Associates deployed in development is the same as that used in manufacturing. So there ARCHITECT (A&E) 502 S. West St. Indianapolis, Indiana 46225 United States is no cost and time associated with scale-up and technology transfer. From a manufacturing standpoint, the capital investment is significantly lower, the ENGINEER/ TLF Engineers Babilonia Engineering Group ARCHITECT (A&E) 3901 W. 86th St., Ste. 200 1223 Cll Juan Ponce de Leon equipment offers a more compact footprint, and the process uses less energy Indianapolis, Indiana 46268 San Juan, Puerto Rico 00926 than what you would see in a traditional wet-granulation fluid-bed drying United States process. So we started on the course because of the gains we would see in CONSTRUCTION Davis & Associates Inc. Fluor Daniel Caribbean, Inc. development, and we have gained continued benefits all the way through to MANAGER 2852 N. Webster Ave. Parkside Plaza Indianapolis, Indiana 46219 Ste. 500 commercial manufacturing.” United States St. 2 No. 14 Metro Office For his part, Pletcher credits the teams’ close working relationship for the Park Guaynabo, Puerto Rico project’s success. “We had an unprecedented level of collaboration,” he says. 00969 “Finding ways to replicate that team effectiveness and cross-functional team- MAIN/GENERAL Davis & Associates, Inc. Alproem Engineering work on other projects would be beneficial on any other endeavors that we CONTRACTOR/ 2852 N. Webster Ave. Contractors PIPING Indianapolis, Indiana 46219 2135 Carr. 2 undertake. The success of these projects was very much built on how effec- SUBCONTRACTOR/ United States Ste. 15 tively these groups worked together—from development to manufacturing.” HVAC Bayamon, Puerto Rico “Lilly is focused on innovation,” says Sternasty. “We believe that contin- SUBCONTRACTOR 00959-5259 uous manufacturing is an innovative way to provide a reliable, safe supply AUTOMATION Cornerstone Controls Emerson Process Management AND CONTROL 8525 Northwest Boulevard Los Frailes Industrial Park 475 of high-quality medicines, and to be able to bring our product through the SUPPLIER Indianapolis, Indiana 46278 Calle C pipeline, from development to manufacturing, as quickly as we can. So, we United States Ste. 501 are really very pleased with the results of what we have installed here.” ‹› Guaynabo, Puerto Rico 00969 Prozess Technologies 6124 Delmar Blvd. St. Louis, Missouri 63112 United States MAJOR EQUIPMENT Korsch America CDM SUPPLIER 18 Bristol Dr. 197 Stone Castle Road South Easton, Massachusetts Rock Tavern, New York 12575 02375 United States United States
Bruker Optics, Inc. 5465 East Cheryl Parkway Madison, Wisconsin 53711 United States MAJOR EQUIPMENT Coperion K-Tron SUPPLIER 590 Woodbury Glassboro Rd. Sewell, New Jersey 08080
Gericke USA, Inc. 14 World’s Fair Dr. Ste. C Somerset, New Jersey 08873-1364 United States
22 | 2017 Facility of the Year Awards FOYA 2017— PROJECT EXECUTION May 2017 | 23 2017 May Project mission Project plant manufacturing FDA-approved a fully operational, Create the end of 2016 by in Ireland area campus Total sq. ft. 55,627 JAZZ JAZZ PHARMACEUTICALS lives patients’ on improving focuses Jazz Pharmaceuticals meaningful commercializing and identifying, developing, by needs. unmet medical address that products ecution Y WINNERY WINNER oject Ex TEGORTEGORTEGORTEGOR Pr CACACA Location Monksland, Athlone Ireland Roscommon, Co. Project Rock Project “Without any prior any “Without of in the building experience Jazz facilities, manufacturing together put Pharmaceuticals on a drawn a small team sources, of external variety were recruits that ensured aligned with the company’s and objectives, culture a greenfield- and delivered very against facility licensed targets.” aggressive SECTION TITLE
SCOPE, TIME, AND BUDGET: A ZERO-COMPROMISE APPROACH
cope, time and budget: These are the ishing, as the right things to do.” and submitted their planning application to the key variable components of any pro- The drug in question, Xyrem, is used to treat local authorities in Ireland. Groundbreaking took ject. If one of the three deviates from narcolepsy. Jazz had seen significant growth in place on an extremely wet 10 February 2014. Splan, the other two are always affect- demand for Xyrem since 2005, and decided to “We had had six months of rain practically every ed. But for Jazz Pharmaceuticals, compromise build a new facility and manufacture the product day that winter, which made us quite nervous,” was not an option. The company’s unwillingness on its own. This was a bold move for a company says Mac Neice. “Fortunately, it stopped raining to settle for something less than perfect led to that had no prior manufacturing experience. Un- the next day and we had dry weather for the the building of a state-of-the-art manufacturing til then, Jazz had outsourced all its production; next three months, which made our construction facility in Athlone, Ireland. contract manufacturers had been producing Xy- people very happy.” In March 2013, Alan Mac Neice, Executive rem since 2005. Mac Neice’s team moved into a temporary Director and Site Leader of the Athlone facility, office located a mere 200 meters from the pro- was appointed to lead a project without defined AHEAD OF SCHEDULE AND ject site in June 2014. “Our team spent their time parameters. UNDER BUDGET working on parallel projects, such as manufac- “In the early stages of the project, the scope In October 2013, the Board of Directors approved turing and quality management systems, writing of what we wanted to do wasn’t clear,” explains the scope and budget for the company’s plan to the procedures, working out how the technology Mac Neice. “We wanted to improve the control build a new facility on a 17.5-acre lot in Athlone, a transfer would work, as well as reviewing and of quality and the supply chain as these per- town located in central Ireland between Galway approving the design as it progressed,” he says. tained to patients. Our aim was to pick several and Dublin. The company had a budget of €46.2 Between June and September 2014, Mac- supply-chain operations or components and million ($50 million) and a target date of late Neice grew his team to a full complement of 26. identify them as the most important areas for June 2016 to obtain approval from the US Food “They were working on all the things you need us to take control of. We looked at a huge range and Drug Administration (FDA). The facility also to do to have a fully operational pharmaceutical of options (e.g., manufacturing of raw materials, had to be provisioned for future expansion and manufacturing site,” says Mac Neice. “So when of the active ingredient, or of the drug product) accommodate the manufacture of new products. we moved into the building—which we did be- and finally settled on manufacturing of the drug Following budget approval, Mac Neice and his fore it was finished in April 2015—we were able product, as well as packaging, labeling, and fin- team (of six at the time) completed the design to hit the ground running by using the team to
24 | 2017 Facility of the Year Awards JAZZ PHARMACEUTICALS PROJECT EXECUTION
THE PROJECT COMPLETED ITS short-term compromises were inevitable, they quickly adopted a mitigation plan. “At one point, PERFECT TRIO OF FULL-SCOPE we had a schedule challenge during the construc- IMPLEMENTATION, DELIVERED AHEAD tion phase, which we addressed by deploying ad- ditional resources and working extra hours. So, we OF SCHEDULE, AND UNDER BUDGET. compromised on our budget. But once we had the plan in place to return to our schedule, we started exploring ways to recover that money from an- support the facility’s commissioning and quali- the project that led to its success. “All my life,” other part of the project. That’s an example of our fication. We were also able to start executing on he says, “I’ve been asked which is the most im- refusal to compromise on any of the three compo- our business systems, leading to the manufac- portant component of the three—scope, time, nents in the long run. We might compromise on ture of validation batches at the end of October or budget. On this project, all three components a short-term basis, but we always thought about 2015, which led to regulatory submissions later were equally important.” how we could remediate or mitigate the compro- that year and in early 2016.” While his team knew that challenges and mise we had just made.” On 8 April 2016, Ireland’s Health Products Regulatory Authority granted authorizations for the manufacture of Xyrem and investigational medicinal products at the facility. Just over two months later, on June 27, the staff was informed that the US FDA had approved Jazz’s Prior Ap- proval Supplement (PAS) to manufacture Xyrem at its new facility. The project came in 2.4% under budget, com- pleting its perfect trio of full-scope implemen- tation, delivered ahead of schedule, and under budget.
RECIPE FOR SUCCESS According to Mac Neice, Jazz set out to achieve these goals right from the start. “Even with only 10% of the design done, we mapped it out and set the date on which we wanted FDA approv- al, which was to be 29 June 2016,” he explains. “That was the fastest possible timeline. We al- ways talked about the day; we didn’t talk about the week or the month or the quarter. And the dynamic we set among all our business partners and our own team was that every day matters, which had a huge psychological impact on how people thought.” In terms of factors for success, Mac Neice says that what might have appeared to be weaknesses turned out to be great strengths. “We had no pre- existing infrastructure support or guidance on how to do this, which meant nobody was locked into a particular way of thinking. It meant we could really focus on what we wanted as an outcome. “And the fact that the team was so small made decision-making very easy. Some of our business partners have remarked that these were key factors of success—that our team was small and how that allowed us to make decisions quickly.” Mac Neice also noted that it was his team’s unwillingness to compromise on any aspect of
May 2017 | 25 JAZZ PHARMACEUTICALS PROJECT EXECUTION
Additionally, the company made conscious efforts to build a strong KEY PROJECT PARTICIPANTS working team and a culture where employees felt appreciated while also being challenged. “Our turnover rate has been very low. We have a culture MANUFACTURER/OWNER Jazz Pharmaceuticals Monksland where people were being challenged every day to be at their best, and to Athlone, Co. Roscommon, Ireland develop beyond it. That really ignites people. We targeted the type of peo- ple who would enjoy that kind of development and wanted to work in an ENGINEER/ARCHITECT (A&E)/ PM Group CONSTRUCTION MANAGER Killakee House environment that is constantly changing.” Belgard Square Ultimately, Mac Neice says, the project’s success comes down to the Tallaght, Dublin 24, Ireland team. “It was our staff who were successful in what they did, and this pro- MAIN/GENERAL CONTRACTOR John Sisk & Son ject has been a constant reminder to me that people create success. No Wilton Works matter what enablers you put in place, nothing will succeed unless your Naas Road staff is successful. We’re a small team in a company that had never done Clondalkin, Dublin 22, Ireland anything like this before—in a town in the middle of Ireland—and we be- ELECTRICAL CONTRACTOR Suir Engineering lieved we could be world-class. Investing in people and in your business Unit 9a Cleaboy Business Park culture makes that happen.” ‹› Old Kilmeaden Road Waterford, Ireland
PIPING/HVAC SUBCONTRACTOR Leo Lynch 16 Fonthill Industrial Park Fonthill Road North Clondalkin, Dublin 22, Ireland
AUTOMATION AND CONTROL SUPPLIER Rockwell Automation IDA Business Park Carrigtwohill, Co. Cork, Ireland
MAJOR EQUIPMENT SUPPLIER Marchesini Group S.P.A. Via Nazionale 100 40065 Pianoro Bologna, Italy
Kells Stainless (ABEC) Cork Road Fermoy, Co. Cork, Ireland
Extract Technology Bradley Junction Industrial Estate Leeds Road Huddersfield HD2 1UR, United Kingdom
26 | 2017 Facility of the Year Awards FOYA 2017—HONORABLE MENTION
PT. KALBIO GLOBAL MEDIKA
PT. Kalbio Global Medika is a biologics and biotechnology company, and wholly owned by Kalbe Farma, the largest Honorable Mention healthcare provider in Indonesia and the largest publicly listed pharmaceutical company in Southeast Asia.
“A point of pride for Kalbio is their quality management system (QMS), designed in accordance with PIC/S standards. The QMS, which integrates all aspects of manufacturing, will support Kalbio’s ambitions to expand its products to regional and international markets.”
Project Project mission Biotechnology Facility Produce quality biotechnology products for local and international markets Location Jakarta, Indonesia Total facility fl oor area Land: 118,402 sq. ft. Site: 180,015 sq. ft.
May 2017 | 27 SECTION TITLE
INCREASING EFFICIENCY WHILE REDUCING CARBON FOOTPRINT
ocal firms make some 70% of all drugs Given its high quality-assurance standards, was Obat dan Makanan [BPOM]) in the second consumed in Indonesia,* yet 90% of Kalbio faced challenges both during construc- half of 2018. the raw materials required to make tion and when procuring equipment. Certain Lthem are imported. Raw materials are vendors didn’t understand the fit and finish the AN EGALITARIAN susceptible to currency fluctuations, which can company expected. In addition, the equipment STRUCTURE affect drug costs for patients. To control costs, requested was not necessarily the equipment As the project progressed through design the Indonesian government took steps to en- vendors wanted to sell. “Some vendors think and construction, Kalbio’s management team courage in-country biologics and biotechnology that because you are in the Far East and you are adopted a staffing idea that Sweeney had seen manufacturing. PT Kalbe Farma, the country’s an Asian company, they can sell you any sort when he worked in the United Kingdom. “We largest pharmaceutical company, formed PT. of system they find is more suitable for their hired 30 postgraduates who were just getting Kalbio Global Medika in response to the govern- own manufacturing purposes,” says Sweeney. out of college and we gave them a one-year ment’s call to action. “We had a user requirement document stating training in biotech techniques,” he says. “And we Kalbio’s Senior General Manager, Christopher what we wanted, and that wasn’t the standard had great support from the international vendors Sweeney, jokes with a hint of pride that nothing system that vendors had been selling across because they saw the value of this. It was very would seem out of place if his facility were in Southeast Asia.” pleasing to have the full support of Merck, GE, and San Diego or Boston, “except, perhaps, the palm The facility was completed in November 2016, Bioquell in helping us start up our facility.” trees.” The $35-million facility of almost 40,000 4% under budget. Kalbio expects to obtain its li- sq. ft. is built on a plot in the Cikarang Industrial cense to manufacture from Indonesia’s National * Source: Indonesian National Drug and Food Control Agency Park on the east side of Jakarta. Drug and Food Control Agency (Badan Penga- (Badan Pengawas Obat dan Makanan [BPOM])
28 | 2017 Facility of the Year Awards PT. KALBIO GLOBAL MEDIKA HONORABLE MENTION
Today, Kalbio employs approximately 90 people, with plans to expand SWEENEY SPEAKS to about 120 later in 2017. And as he does when talking about the facility, Sweeney speaks proudly of his staff, whose average age is 24. “They are all PROUDLY OF HIS STAFF, highly trained, educated, and motivated to get things done,” he says. “We WHOSE AVERAGE AGE IS 24. also have a very egalitarian structure, an open-plan office, and an open-plan canteen; everybody is equal. We are all part of the same machine, we work “THEY’RE ALL HIGHLY as a team.” TRAINED, EDUCATED, AND INDUSTRY BEST PRACTICES MOTIVATED TO GET Seeing inefficiency in the process, Kalbio has used a progressive approach THINGS DONE.” to validation. As part of their service delivery, vendors perform an installa- tion qualification (IQ)/operational qualification (OQ) on all the company’s bespoke systems. To avoid duplication, the company has streamlined pro- cesses so that testing done, say, at the factory acceptance testing (FAT) or KEY PROJECT PARTICIPANTS the site acceptance testing (SAT) stages is not repeated in the IQ or OQ stage. “We just reference the FAT and the SAT testing in the IQ or OQ docu- MANUFACTURER/OWNER PT. Kalbio Global Medika Jl. Soka Blok F19 no. 002 ments,” says Sweeney, “thereby saving a lot of time and money.” Kawasan Industri Delta Silicon 3 Lippo Cikarang The company has also implemented a full quality management system Bekasi 17530, Indonesia that is compliant with PIC/S guidelines; Sweeney adds that Kalbio is one of ENGINEER/ARCHITECT (A&E) PT. Puricipta Felicita the first biotech companies in Southeast Asia to adopt a risk-based approach Jl. Nuri I Blok Y 4 No. 2 to manufacturing. Tangerang Banten, Indonesia Additionally, Kalbio set out to reduce its demand on resources. To this end, for example, the facility’s air handling units (AHU) condense 700 liters of wa- PT. Metakom Inti Perkasa (M/E) ter from the atmosphere per hour—for a total of 16 cubic meters of water Perkantoran Prisma Kedoya Plaza Blok D No. 11 Jl. Raya Perjuangan, Kebon Jeruk per day—which is then reused. The AHUs are also turned down overnight to Jakarta Barat 11530, Indonesia further reduce electricity demand. “Basically, we have tried to do as much as we can to reduce our carbon footprint,” says Sweeney. “And while it costs PT. Ketira Engineering Consultants (structure) Jl. Tanah Abang V/56-56A money to implement these measures, they save money in the long run.” Jakarta Pusat 10160, Indonesia For Sweeney, receiving a 2017 FOYA Honorable Mention “is a great achievement for Kalbio, for my team, but also for the Indonesian biophar- CONSTRUCTION MANAGER PT. Limas Rekayasa Jl. Gandaria Raya Blok GG 4/1 ma industry. I hope it spurs other companies to do the same, and send in Sukatani Permai their FOYA applications when they have finished their facilities.” ‹› Sukatani TaposDepok 16454 West Java, Indonesia
PIPING SUBCONTRACTOR Xact Engineering Sdn. Bhd 13-2 Jalan Anggerik U31 U Kota Kemuning Section 31 40460 Shah Alam Selangor D. Ehsan, Malaysia
HVAC SUBCONTRACTOR PT. Taiyo Sinar Raya Teknik Summitmas I Lantai 7 JL. Jend Sudirman Kav 61-62 Kebayoran Baru Jakarta Selatan 12190, Indonesia
AUTOMATION AND CONTROL PT. Azbil Berca Indonesia SUPPLIER CCM Building, 5th Floor Jl. Cikini Raya No. 95 Jakarta 10330, Indonesia
MAJOR EQUIPMENT SUPPLIER BWT Pharma & Biotech GmbH Carl-Benz-Strasse 4 D-74321 Bietigheim-Bissingen, Germany
Dara Pharmaceutical Packaging Industrial Zone Coll de la Manya Galileo Galilei, 5-19 08403 Granollers Barcelona, Spain
May 2017 | 29 FOYA 2017—HONORABLE MENTION
NEPHRON PHARMACEUTICALS CORPORATION
Honorable Mention Nephron Pharmaceuticals specializes in blow-fi ll-seal (BFS) manufacturing, a technology in which a vial of medication is formed, fi lled, and sealed in a continuous process, without human intervention in a sterile, enclosed area.
“Nephron is being recognized for using and integrating a suite of industry-leading technologies such as laser- guided vehicles, automated warehousing, robotics, and track-and-trace technology. The company is also recognized for its significant infrastructure investment in West Columbia and its commitment to using local talent from nearby universities and trade schools. In addition, the facility’s viewing areas and access were designed to facilitate students’ and visitors’ exposure to the pharmaceutical industry, thereby helping to promote and advance pharmaceutical manufacturing careers.”
Project Project mission Nephron SC Build a state-of-the-art automated manufacturing facility
Location Total facility fl oor area West Columbia, South Carolina, US Land: 2,317,140 sq. ft. Site facility: 408,000 sq. ft.
30 | 2017 Facility of the Year Awards AUTOMATED, STATE OF THE ART, AND COMMUNITY FOCUSED
hen Nephron Pharmaceuti- its many benefits, including proximity to universi- ment throughout our facility is custom-made, cals Corporation was at full ties and colleges, the state’s deep manufacturing spec’d out by our own design engineers, and in- production capacity and no labor pool, accessibility to three major interstate tegral to making sterile aseptic medications and Wlonger able to keep up with highways, and the ability to receive materials via eliminating risk.” sales growth at its facility in Orlando, Florida, rail car, which Kennedy says significantly lowers The entire manufacturing process utilizes a President and CEO Lou Kennedy knew some- the costs of raw materials. variety of systems to operate with the utmost thing needed to be done: expand the existing Although architects and engineers provided safety and efficiency. It includes: facility or build a new one altogether. “We were an initial construction estimate of three to five Automated filling via BFS technology: selling everything that we could produce; we years, Kennedy and her team completed it all Rommelag BFS machines are used to form, had no excess capacity,” says Kennedy. “So we in a much shorter timeframe. “We completed fill, and seal vials in an aseptic environment purchased 60 acres in Orlando next to the origi- the project—from implementation through val- with no human interaction, a technology that nal facility. However, several things occurred that idation, to obtaining FDA approval, to official produces a highly repeatable and safe drug made doing business in Orlando difficult, and opening in late 2015—in three years,” she says. product. Kennedy reached out to South Carolina, which “It was a really aggressive timeline, and we are Automated warehousing: The Elettric80 welcomed Nephron with open arms. very proud of that.” warehouse and laser-guided vehicle system Nephron now has a state-of-the art facility automatically retrieves and stores pallets of featuring automated BFS manufacturing, robot- STATE OF THE ART finished goods as well as works in progress. ics, laser-guided vehicles, and the most recent Nephron designed its South Carolina facility to Automated packaging: Bosch packaging quality control and automation systems. be a world leader in BFS manufacturing. The technology lines are used to package BFS In February 2011, feasibility studies and design unique aspect of the new plant, which utilizes products efficiently for sale to hospitals and began on a new 408,000-sq.-ft. facility budget- eight BFS machines to produce inhalation drugs, home users. Packaging includes printing ed at $245 million. Construction got underway a is its high level of automation. “We are making and verification operations to prevent little more than a year later, in April 2012, in West sterile drugs that require no human intervention, counterfeiting and allow tracing of products Columbia, a city of approximately 15,000 located and that’s important because there is no chance through the supply chain. in the center of the state. The site was selected for for error,” says Kennedy. “Each piece of equip-
May 2017 | 31 NEPHRON PHARMACEUTICALS CORPORATION HONORABLE MENTION
“WE ARE MAKING STERILE DRUGS THAT REQUIRE NO HUMAN INTERVENTION, AND THAT’S IMPORTANT BECAUSE THERE IS NO CHANCE FOR ERROR”
A laboratory information management system and MODA, a paperless quality-control microbiology solution, are used to automate and control Nephron’s laboratory systems. Plant-wide OSISoft PI historian and manufacturing information systems are deployed as part of an overall automation strategy. These systems include a track-and-trace component that allows product in all phases of production to be accurately followed via barcodes and other verification methods.
“No BFS facility anywhere around the globe is as automated as ours,” says Kennedy. “While employees formulate the drugs at the start of the process using an automated formulation software, and then load trucks at the very end, every step in between is 100% automated. We are constantly tracking all the metrics, and through software we can adjust on every piece of equip- ment. This is a unique pharma plant.” KEY PROJECT PARTICIPANTS ABILITY TO EXPAND The facility was also built with expansion in mind. “Our utilities are over- MANUFACTURER/OWNER Lou Kennedy 4500 12th St. Ext sized so that as the company grows new lines can be added and the in- West Columbia, South Carolina 29172 United States frastructure can support the growth,” Kennedy says. Company growth ENGINEER/ARCHITECT (A&E) AEI Engineering can come from three sources: increased sales of currently manufactured 14055 Riveredge Dr. inhalation solutions, sales of drug products that Nephron pursues based Suite 170 Tampa, Florida 33602 United States on market analysis, and sales of drug products on drug shortages lists that align with BFS technology. CONSTRUCTION MANAGER Jim Bennett 4500 12th St. Ext. Kennedy, and indeed all of Nephron’s 330 employees, take great pride in West Columbia, South Carolina 29172 United States the new facility. Kennedy is especially pleased with the company’s contri- MAIN/GENERAL CONTRACTOR Jack Jennings and Son bution to the community. The building was designed so that all aspects of 1030 Wilfred Dr. the production process are visible to visitors—which often include custom- Orlando, Florida 32803 United States ers and schoolchildren. Nephron also has an intern program for college and J. Raymond Construction high school students. “We’re trying to inspire young folks to pick careers in 465 W. Warren Ave. pharma and in high-tech manufacturing. I think that is a good testament of Longwood, Florida 32750 United States what the company hopes to encourage,” says Kennedy. ‹› PIPING / HVAC Century Contractors SUBCONTRACTOR 5100 Smith Farm Rd. Matthews, North Carolina 28104 United States
AUTOMATION AND CONTROL Elettric80 spa SUPPLIER Via Guglielmo Marconi, 23 42030 Reggio Emilia, Italy MAJOR EQUIPMENT SUPPLIER Robert Bosch LLC 38000 Hills Tech Drive Farmington Hills, Michigan 48331 United States
Rommelag USA, Inc. 27905 Meadow Drive, Suite 9 Evergreen, Colorado 80439 United States
32 | 2017 Facility of the Year Awards
Project mission Project medicine via personalized cancer for treatments effective Find more oor area fl facility Total sq. ft 23,610 NOVARTIS AND AND NOVARTIS OF UNIVERSITY PENNSYLVANIA provides that company is a global health care Novartis of patients needs evolving the address solutions to worldwide. strives that medical center Medicine is an academic Penn being of people through well the health and improve to service. and community clinical care education, research, able Mention Honor Location US Philadelphia, Pennsylvania, Project Project for Center Novartis-Penn Therapies Cellular Advanced “This facility leverages leverages facility “This engineering pharmaceutical successfully principles to academic, corporate, merge and medical considerations, center an innovative creating personalized advance to project The medicine. the development advances models operating of new of the potential harness to medicine.” personalized
FOYA 2017—HONORABLE MENTION Awards of the Year Facility 34 | 2017 ADVANCING INNOVATIVE CANCER THERAPIES
n August 2012 the Novartis Institutes for Bio- signed for cell engineering and 24,000 sq. ft. of requires specialized facilities: the clinical cell and Medical Research, based in Cambridge, Massa- laboratory and cell therapy manufacturing space vaccine production facility, a quality control lab, chusetts, and the University of Pennsylvania’s with the capacity to manufacture cellular thera- a transformational and correlative studies lab, IPerelman School of Medicine (Penn Medicine) pies for up to 400 patients per year. and a product development lab. This approach announced they had entered into an exclusive “The CACT will allow us to leverage this pro- promotes what the center calls a “new scientific global research and licensing agreement. Under gress to develop and test new approaches more workplace culture,” which blurs the boundaries the alliance, Penn Medicine granted Novartis an quickly,” says Carl H. June, MD, the Richard W. across disciplines and encourages collaboration. exclusive worldwide license to the technologies Vague Professor in Immunotherapy at Penn The center was designed and built to meet used in an ongoing trial of patients with chronic Medicine. “At the same time, we’ll be able to current good manufacturing practice clean- lymphocytic leukemia (CLL) as well as future ther- expand our ability to manufacture personalized room standards, including ISO Class 10,000 cell apies based on chimeric antigen receptor (CAR) cell therapies for a greater number of trials.” processing rooms and ISO Class 100,000 sup- technology developed through the collaboration. port spaces. The flow of specimens, materials, As part of the agreement, Novartis invested $20 A NEW SCIENTIFIC and staff has also been carefully considered million to establish the $27-million Center for Ad- WORKPLACE CULTURE to ensure the highest standard of cleanliness vanced Cellular Therapies (CACT) and to support Although the CACT is primarily a lab and research throughout the facility. future research in CAR technology. space, the project design team brought in experts These and other design decisions are intend- Construction on the CACT—formally known as from outside the fields of science and technology ed to improve collaboration and communication the Novartis-Penn Center for Advanced Cellular with a view to making the facility more efficient among the teams, helping them increase speed to Therapeutics—began in December 2014, and and effective. They also included specialists in market and produce individual patient therapies the facility opened in early 2016. It adjoins the corporate workplace design to create the best more efficiently. The strategic layout and organi- existing cancer therapeutics floor in the Smilow environment possible for employees. zation of lab equipment will also dramatically cut Center for Translational Research, allowing it to Open-plan laboratories within the facility al- the time it takes to generate “hunter” cells: While be fully integrated into Penn Medicine’s research low researchers from the center’s four principal it previously took a month to produce these thera- and clinical operations. The CACT employs 100 investigator (PI) teams to work together rather peutic agents for each patient, the new facility will highly specialized professionals working across than in silos, as in many lab facilities. Each PI team help reduce the time to two weeks. 6,300 sq. ft. of cleanroom space specially de- works on different aspects of the research, which The CACT advances this process through the
May 2017 | 35 NOVARTIS AND UNIVERSITY OF PENNSYLVANIA HONORABLE MENTION
different functional areas contained within the facility, such as vaccine de- velopment, assay development, and correlative studies of blood and other bio specimens, to examine how trial participants respond to the therapies they receive.
EXCITING NEW THERAPIES In addition to continued trials in CLL, Penn has engineered T cell trials un- derway for other types of leukemia, as well as lymphoma, mesothelioma, myeloma, and neuroblastoma. In 2014, the US Food and Drug Administration awarded breakthrough therapy designation to CTL019, an investigational CAR therapy for the treatment of relapsed and refractory adult and pediatric acute lympho- blastic leukemia. CTL019 is the first personalized cellular therapy for the treatment of cancer to receive this important classification. Pioneered by Penn Medicine, this new application first removes a pa- tient’s T cells, then genetically reprograms them in the CACT’s clinical cell and vaccine production facility. After being infused back into the patient, these hunter cells both multiply and attack, targeting tumor cells that ex- press the DCD19 protein. Tests reveal that each single engineered cell can grow into an army of more than 10,000. Ultimately, the CACT’s objective is to develop new treatment options for life-threatening diseases. “This new joint center is testimony to the power that comes from merging academic discovery and the generation of new medicines,” says Mark Fishman, President of Novartis Institutes for BioMed- ical Research. ‹›
KEY PROJECT PARTICIPANTS MANUFACTURER/OWNER Penn Medicine: University of Pennsylvania Health System Philadelphia, Pennsylvania, United States
ENGINEER/ARCHITECT (A&E) CannonDesign 225 North Michigan Ave. Ste. 1100 Chicago, Illinois 60601 United States
Ballinger 833 Chestnut St. Ste. 1400 Philadelphia, Pennsylvania 19107 United States
CONSTRUCTION MANAGER L. F. Driscoll Company, LLC 3600 Civic Center Blvd. 7th Floor Philadelphia, Pennsylvania 19104 United States MAJOR EQUIPMENT SUPPLIER AES Clean Technology, Inc. 422 Stump Rd. Montgomeryville, Pennsylvania 18936 United States
36 | 2017 Facility of the Year Awards