Volume 21 Issue 3 | July/August/September 2020 TM SHOW ISSUE CPhI: Festival of Pharma BIO Investor Forum - Digital 2020 ISPE Annual Meeting & Expo - Virtual CONTRACT MANUFACTURING Biologics CDMO Trends and Opportunities in China SUPPLY CHAIN Building Future-Proof Supply Chains with Graph Technology CLINICAL TRIALS Decentralization: A Direct Approach to Clinical Trials www.pharmoutsourcing.com Large enough to deliver, small enough to care. Balancing... ANALYTICAL SERVICES With over seven decades of experience, Mission Pharmacal Liquids has mastered the equilibrium of expertise and efficiency. DEVELOPMENT Our mid-sized advantage allows flexibility, responsiveness, and unmatched support in executing your vision while MANUFACTURING Semi-Solids providing a wide range of specialized services for products at any stage of their life cycle. 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CDMO SERVICES: Small Molecules Large Molecules Process Development Oligos & Peptides High Potency & ADC Aseptic Fill Finish WHAT DO YOU WANT TO MAKE? www.AjiBio-Pharma.com FROM THE EDITOR Editor's Message Effi ciency: One Step at a Time I like to think that in a previous life (or maybe in a future life) I was an effi ciency expert. Set out a couple of tasks for me, or a couple of errands, and I like to fi gure out how best to approach them – what’s the best route, what will entail the least eff ort, what’s easiest. But I guess most people are like that. Who wants to waste time or eff ort if you can be more effi cient? For many years, the pharmaceutical industry was rather ineffi cient. But who could blame them? When profi ts are high, it’s ok to be ineffi cient – especially in your manufacturing operations. Furthermore, if your process is running and the FDA has approved it – why fi x something that, technically, isn’t broken and open yourself up for another round of inspections? The short answer is no one did it. If you were pumping out enough product to meet demand and fi nancial goals – no one was really concerned if a batch or two was out of spec. Just toss it – and make more. But, time marches on, economics change, and manufacturing effi ciency is now the big game in town. Perhaps the biggest advancement in manufacturing effi ciency has been the introduction and ongoing refi nement of continuous processing. Continuous processing technologies allows manufacturers to eliminate the stopping and starting of processes as material is moved from one step to another. Less steps means more effi ciency. Effi ciency improvements have also found their way into the drug discovery arena – companies are now using advanced data analytics to predict which compounds have the best chances of success. The mantra of “Fail early” is a good one. Eliminate the less promising compounds and focus on the most promising products. And, of course, the COVID-19 pandemic has shown us other ways to be more effi cient and improve processes. Decentralizing clinical trials and making them more “virtual” shows promise and is an ideal way to make sure clinical trials move along as planned. Virtual vendor visits are supplanting in person visits. While due diligence has to be done, in a socially distancing world, where projects have to move forward, a video tour/audit can be an effi cient way to start a vendor/client relationship. Finally, supply chains need a good looking at. If anything, the pandemic has shown that supply chains are more fragile than we thought, and the longer the supply chain is – the more likely problems will arise. Effi ciency will come. But, as with most change – it will come one step at a time. The key is to make the most out of each step and not waste any eff ort. Mike Auerbach Editor In Chief [email protected] Pharmaceutical Outsourcing | 2 | July/August/September 2020 OUR TEST, YOUR CURE... 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ACC combines robust reagents, analysis and technical service expertise, to provide you with diverse solutions for endotoxin and glucan testing. • 888.395.2221 www.acciusa.com PN18-003 JULY/AUGUST/SEPTEMBER 2020 | VOLUME 21, ISSUE 3 From the Cover 12 | CONTRACT MANUFACTURING Biologics CDMO Trends and Opportunities in China Vicky Xia and Leo Yang BioPlan Associates, Inc. 32 | SUPPLY CHAIN Building Future-Proof Supply Chains with Graph Technology Amy Hodler, Director of AI Graph Analytics Neo4j 46 | CLINICAL TRIALS Decentralization: A Direct Approach to Clinical Trials Nicole Gray, Director, Strategic Supply Solutions Catalent Pharma Solutions Pharmaceutical Outsourcing | 4 | July/August/September 2020 JULY/AUGUST/SEPTEMBER 2020 | VOLUME 21, ISSUE 3 In this Issue 10 | INSIDER INSIGHT 40 | CONTRACT MANUFACTURING Adjusting to a New Normal in API Manufacturing Critical Requirements of the Mid-Range Tablet Press Ed Price, President Frederick Murray, President Seqens North America KORSCH America Inc. 16 | CONTRACT MANUFACTURING 42 | CONTRACT MANUFACTURING Pre-Filled Syringes: Development Challenges and the Adeno-Associated Virus (AAV) Vector Gene Therapy - Value of Partnership From Idea to IND Anish Parikh, Vice President, Drug Product Sales & Marketing Vibhor Gupta, Ph.D. and Jaleel Shujath, MBA AMRI Absorption Systems 20 | CONTRACT MANUFACTURING 50 | CONTRACT RESEARCH Outsourcing Solid Dose Manufacturing Trends The Importance of Effective Data Capture and In-Lab Erik Haeffler, Vice President of Manufacturing Services Tech for Bioanalytical CROs: Implications for Quality and Recipharm Customer Satisfaction Graeme Dennis, Commercial Director, Preclinical Pharma 24 | CONTRACT MANUFACTURING IDBS Overcoming Challenges with Amorphous Materials 54 | CLINICAL TRIALS during Micronization Fergus Manford, Matthew Green and David Thomas Planning for Success in Early Phase Clinical Trials Vectura Nariné Baririan, Pharmacokinetic and Clinical Pharmacology Expert SGS 28 | CONTRACT MANUFACTURING 57 | CONTRACT MANUFACTURING Bioprocessing 4.0 – Where Are We with Smart Manufacturing in 2020? Ensuring Safety When Using Hazardous Chemistry Mark Demesmaeker, Head of Data Analytics Sam Brogan, PhD, Lab Project Manager, Research & Development Dan Kopec, Process Analytical Technologies Expert Sterling Pharma Solutions Artur Miguel Arsénio, Head of Product Management PAT, Automation & Software Sartorius REGULAR FEATURES 34 | CONTRACT MANUFACTURING 2 EDITOR'S MESSAGE 6 EDITORIAL ADVISORY BOARD What if Jumping Through Regulatory Hoops Had an Upside? 8 CN PERSPECTIVES Xavier Duburcq, CEO 9 SOCIAL MEDIA CONNECTIONS ProductLife Group 60 2020 INTERPHEX AWARD WINNERS 36 | ANALYTICAL TESTING 62 HORIZON LINES Preclinical Testing: Advice for the Smaller 66 INDUSTRY NEWS Drug Developer Mark Walker, Senior Technical Director of Toxicology 72 ADVERTISER’S INDEX WuXi AppTec Laboratory Testing Division pharmoutsourcing.com | 5 | July/August/September 2020 EDITORIAL ADVISORY BOARD Editorial Advisory Board Rafik H. Bishara, PhD Robert A. Goodnow Jr., PhD Joseph Swaroop Mathen, PhD Technical Advisor Discovery Chemistry, Lead Generation Director, Chemistry Hoffmann - La Roche Inc. Cambrex High Point Jon Denissen, PhD Wayne Heminway Senior Vice President Business Development Executive Eduardo Motti, MD PPD Laboratories Cook Pharmica LLC Owner Trials & Training Consult William Downey Derek Hennecke President CEO Daniel L. Norwood, PhD HighTech Business Decisions Xcelience Distinguished Research Fellow Boehringer Ingelheim Pharmaceuticals, Inc. David P. Elder, PhD Dennis Jenke, PhD Baxter Distinguished Scientist Director, Scinovo Group Technology Resources Division Paul Skultety, PhD GlaxoSmithKine R&D Baxter Healthcare Corporation Director, Pharmaceutical Development Services Xcelience, LLC Nicolas Fourrier, PhD Hemant N. Joshi SGS Founder Tara Innovations LLC Scott M. Wheelwright, PhD Dr. Nancy A. Gillett Founder, Complya Asia Co., Ltd. Corporate Executive Vice President Eric S. Langer, MSB Strategic Manufacturing Worldwide, Inc. President and Managing Partner and President, Global Preclinical Services BioPlan Associates, Inc. Charles River Laboratories Karen Zuklie Max Lazar Director of Project Planning C. Ray Goff, Jr. President in Medical Research Operations RKG Solutions, LLC FDA Regulatory Compliance Consulting Purdue Pharma LP Pharmaceutical Outsourcing Published by CompareNetworks, Inc. 395 Oyster Point Blvd #300 South San Francisco, CA 94080 Volume 21 Issue 3 | July/August/September 2020 USA Fax: 650-873-9038 GROUP PUBLISHER - Laura Zoibi Rice E-mail: [email protected] [email protected] Website: www.pharmoutsourcing.com ASSOCIATE PUBLISHER - Tom Neely Printed in the USA [email protected] Pharmaceutical Outsourcing (ISSN - 1945-3337) is published seven times a year (monthly in Feb., EDITOR IN CHIEF