Integralab® Plus Your Customized Gmp Radiopharmacy Expertise Makes It Happen

INTEGRALAB® PLUS YOUR CUSTOMIZED GMP RADIOPHARMACY www.iba-radiopharmasolutions.com EXPERTISE MAKES IT HAPPEN

Eng. Vincent Petry Process and facility engineer at IBA RadioPharma Solutions

Dr. med. Konrade von Bremen Director at SWAN Isotopen AG, Bern, Switzerland INTEGRALAB®PLUS INTEGRALAB® SOLUTION, CUSTOMIZED ADAPTED TO YOUR NEEDS INTEGRALAB®PLUS is a fully integrated solution, combining equipment and services for RADIOPHARMACY establishing a radiopharmaceutical GMP production center, tailored to your precise needs. PRODUCTION Our approach is truly comprehensive, taking your project from building design to production, with full regulatory compliance and the selection, integration, installation and qualification of equipment that meets your radioisotope production goals.

EXPERT TO maintenance, to ensure the success respect, from expert to expert. The EXPERT, ALL THE of your project, for a sustainable big advantage for you is that a single future. point of contact will manage the WAY establishment of your radiopharmacy, IBA works with you and supports you but at the same time, you can call right through the whole process, from DIRECT ACCESS directly on all IBA in-house experts to our first meeting through design, TO THE EXPERT support you. This approach, unique in setting-up and operation. More than the market, speeds up workflow and that, your IBA expert will support you WHO KNOWS ensures that you’re always talking to throughout the lifetime of your radio- This is a long-lasting relationship, the person with the answers. pharmacy with training, updates and a partnership based on trust and 2 3 REDUCE YOUR INCREASE YOUR STAY AHEAD PLUS ® PROJECT TIME PRODUCTION UPTIME OF TIME

IBA // INTEGRALAB EXPERT TO EXPERT, WE SUPPORT YOU RIGHT THROUGH THE PRODUCT LIFETIME

PROJECT EQUIPMENT PROCESS NUCLEAR PRODUCTION IBA MAINTENANCE SPECIALIST EXTENDED ENDLESS UPGRADE USERS CONCEPTION INTEGRATION VALIDATION MEDICINE EQUIPMENT ACADEMY SERVICES ADVICE EQUIPMENT INNOVATION SUPPORT MEETINGS DEPARTMENT OPERATION SERVICES INTEGRATION

1. DEVELOP YOUR PROJECT 2. MAXIMIZE YOUR PERFORMANCE 3. BUILD YOUR FUTURE Since the project conception of the radiopharmacy at SWAN isotopen AG, Vincent Petry has been providing his expertise with a customized and optimized facility layout, compliant with GMP standards.

Producing PET radiopharmaceuticals in a GMP1 environment Eng. Vincent Petry is complex; you need specialised facilities, with a range of Process and facility engineer at IBA RadioPharma Solutions advanced techniques equipment and experts with hands- on experience of establishing radiopharmacy centers. IBA Dr. med. Konrade von Bremen ® Director at SWAN Isotopen AG, Bern, has successfully installed almost one hundred IntegraLab Switzerland radiopharmacies around the world; this track record is a demonstration of IBA’s experience and expertise.

IBA’s team of experts will help you design and build a radiopharmaceutical production facility, fully customized to meet your needs and your production output requirements. You will work with our in-house experts covering all areas: from the process development, through the business plan and project management, all the way to the validation and regulatory compliance. By working in partnership this way - expert to expert - we can get the job done on budget and on time, with a solution 4 that complies with GMP and produces your radiotracers 5 efficiently. PLUS PLUS ® ®

I thank you for your efforts with respect to the

IBA // INTEGRALAB qualification of the facility and the installations IBA // INTEGRALAB 1. DEVELOP YOUR and for the example SOP2’s. The protocols and SOP’s were very helpful and made great PROJECT impression on the inspectors. REDUCE YOUR PROJECT TIME Dr Adrie P. de Jong, Head of Radiopharmacy Medisch Centrum Alkmaar, The Netherlands

1. Good Manufacturing Practice 2. Standard Operating Procedure 1. DEVELOP YOUR PROJECT

SUPPORT IN ALL ASPECTS OF PROJECT DEVELOPMENT

PROJECT CONCEPTION EQUIPMENT INTEGRATION PROCESS VALIDATION

WHAT’S THE ADVANTAGE BUSINESS PLAN PRODUCTION SOLUTIONS GMP MASTER WITH IBA? à Support to define the FOR PET & SPECT DOCUMENTATION You have direct access to IBA radiopharmaceuticals production à High capacity cyclotron (from 3 MeV à GMP risk management in-house experts on all aspects scope to 70 MeV) and targetry systems à Development of customized of your radiopharmacy, from the à Full range of chemistry systems for à Build your business plan validation master plan (VMP) building design to the GMP and risk radiopharmaceutical production 6 assessment specialist. à Supporting investment/financing, 7 via our network of financial GMP VALIDATION partners PROCESS EQUIPMENT

PLUS à Quality management system PLUS ® à User requirements for specific ® GMP FACILITY DESIGN radiopharmaceutical processes à Batch records for production of premises and equipment 18F-FDG & other àCustomized and optimized facility radiopharmaceuticals layout, compliant with à Supply of production and quality control equipment for à Customized manufacturing IBA // INTEGRALAB GMP standards IBA // INTEGRALAB Pharmacopeial testing equipment, operation and à Facility architectural design and maintenance procedures engineering services PROJECT à Standard operating procedures MANAGEMENT

CLEAN ROOM EXPERTISE à Set-up your PET center on time and FDG MARKET on budget AUTHORIZATION à Integration of radiopharmaceutical laboratories requirements, à One single point of contact à Deliverables based on IBA including special techniques (air MA dossier classification and ventilation) à Guidance to obtain market EQUIPMENT authorization QUALIFICATION SAFETY Protocols for : CONSULTANCY à Risk Analysis à Installation Qualification (IQ) à Monte Carlo shielding à Operational Qualification (OQ) à Technical support from IBA experts simulation report in GMP and/or regulatory affairs ® à Performance Qualification (PQ) YOUR INTEGRALAB à Process validation support RADIOPHARMACY à Radiation monitoring and radiation protection equipment

ENVIRONMENTAL IMPACT à Support for radioactive waste management strategy à Decommissioning guidelines 1. DEVELOP YOUR PROJECT

NUCLEAR MEDICINE We have an IBA Cyclone® 18/9 Cyclotron and I have no hesitation recommending IBA. From initial enquiry, through the installation phase, to day to day running, your DEPARTMENT services are extraordinary. I am very impressed with your professionalism and willingness to help. I thank you so much; especially for the dedication that, despite INTEGRATION being a small center, made us feel very important. I can’t thank you enough ! Walid I. Al Khalidi , Managing Director REACH HIGHER LEVELS Al Khalidi Medical Center Amman, Jordan OF PATIENT CARE

Through the successful completion of many projects around the world, IBA has built up invaluable experience in integrating nuclear medicine departments in healthcare centers. We can now bring this expertise to your hospital, helping you achieve sustainable, market-leading results in patient care, cost efficiency and staff YOUR NUCLEAR MEDICINE satisfaction. DEPARTMENT 8 A single IBA project manager coordinates your project, but you have access to the 9 best technology in terms of radiopharmaceutical production tools, as well as imaging equipment. PLUS PLUS ® ® From design and installation, through full regulatory compliance, we take an integrated approach to patient care optimization, customized to your particular requirements. IBA // INTEGRALAB IBA // INTEGRALAB

EXAMPLES OF OUR PROVEN YOUR PET EXPERIENCE IN BUILDING NUCLEAR WHAT’S THE ADVANTAGE RADIOPHARMACY MEDICINE DEPARTMENTS WITH IBA? A totally integrated approach to à Gliwice, Poland à EMC Elsmed, Moscow patient care. IntegraLab® offers you Construction, building design, lab Building design, lab equipment, highly-efficient workflows thanks equipment, Cyclone® 18, PET/CT, Cyclone® 18 and PET/CT to our seamless integration of all GMP support & Market imaging equipment and software. Authorization à Hanoi, Vietman Building design, lab equipment, à Yerevan, Armenia Cyclone® 30 and PET/CT Building design, lab equipment, Cyclone® 18 and PET/CT & GMP à Tripoli Medical Center, support Tripoli, Libya Building design, lab equipment, à Yangon, Myanmar Cyclone® 11 and PET/CT Building design, lab equipment, Cyclone® 18 and PET/CT As a cyclotron expert, Jean-Michel Geets has DURING been the key contact person for the Arronax project since its conception. He has been su- porting Dr. Ferid Haddad who is managing the operation of a high en- Eng. Jean-Michel Geets ergy (70 MeV) and high ® intensity multi-particle IntegraLab business Cyclone® 70 cyclotron Developer at IBA RadioPhar- for the production of Dr. Ferid Haddad Ph.D ma solutions non-conventional radioi- Director of the GIP Arronax in sotopes since 2008. Nantes, France

When your new production facility is up and running, IBA continues to offer you support and 10 expertise, to optimize uptime and maximize your 11 return on investment. PLUS PLUS ® ® In-house IBA RadioPharma Solutions experts provide you with the latest product innovations,

IBA // INTEGRALAB updates, skills and applications to ensure you IBA // INTEGRALAB maintain leading-edge performance throughout the lifetime of your PET center.

2. MAXIMIZE YOUR PRODUCTION UPTIME SUPPORT FOR YOUR PERFORMANCE 2. MAXIMIZE YOUR PRODUCTION UPTIME

EXPERT SUPPORT TO MAXIMIZE YOUR UPTIME

HIGHEST PRODUCTION IBA ACADEMY MAINTENANCE SERVICES CAPACITY EQUIPMENT à Comprehensive training program à Technical support 24/7 à Up to 30 Ci of 18F per run with the for equipment operation and Cyclone® KIUBE cyclotron maintenance, quality control, à Online access to spare quality assurance, ... parts services à Up to 12 synthesis runs per day System upgrades and updates without opening the hotcell, à Train at IBA centers, at your site or à thanks to the Synthera®+ via internship à Preventive maintenance automatic IFP™ ejection system à Technical audit of your system and loader. SPECIALIST ADVICE

à The average down-time is less à Regulatory affairs changes than 4 days per year with IBA equipment. à Changes to GMP guidance à Impact assessment of changing 12 à Full redundancy to maximize your 13 equipment reliability : Ion source, technology extraction, targetry, synthesis PLUS PLUS ® ® IBA // INTEGRALAB IBA // INTEGRALAB Our IBA Cyclone® 18/9 was installed in 1999 and is still running WHAT’S THE ADVANTAGE to cover all our clinical and research needs. A series of WITH IBA? Unique training with the IBA Academy. upgrades and the outstanding support from IBA has allowed Only a well-trained staff can maximize us to maintain over the years the reliability, efficiency and the uptime of your PET center. The IBA productivity of our cyclotron with an uptime better than 98%. Academy provides the comprehensive training required.

Dr. Yann Seimbille Head of the Cyclotron & Radiopharmaceutical Chemistry Unit and Mr. Elie Eid Cyclotron operator University Hospital of Geneva, Switzerland Dr Vasko Kramer has been a Synthera® user for several years. Starting with FDG, NaF and FCH, Positron- Pharma has been able to include a wide range of clinically relevant tumor tracers for hypoxia (F-MISO), cell proliferation (FLT), protein biosynthesis (FET) and tumor specific recep- tors (68Ga-DOTA-peptides). As a chemistry expert, Dr Gameiro closely collabo- rates with Dr Kramer for new developments.

For as long as you operate an IBA facility we will work with you and help you secure your future by offering improvements that lead to higher performance and productivity, enabling you to produce new radioisotopes and radiopharmaceuticals.

Because technology never stands still, IBA will develop upgrade possibilities tailored to your configuration. Dr. Vasko Kramer Ph.D Our engineers and researchers constantly monitor the Director of Research & Development at PositronPharma, Chile latest technological developments and updates, integrating them into existing systems. Through R&D 14 partnership opportunities and access to a large user’s 15 base, IBA RadioPharma Solutions will help you stay ahead

PLUS of time. PLUS ® ® IBA // INTEGRALAB IBA // INTEGRALAB 3. STAY AHEAD OF TIME BUILD YOUR FUTURE, IT’S ABOUT ENDLESS INNOVATION

Dr. Cristiana Gameiro Ph.D Product Manager at IBA RadioPharma Solutions 3. STAY AHEAD OF TIME

WHAT’S THE ADVANTAGE WITH IBA? IBA will help you stay one step ahead in reliability and technology, offering you constant improvement possibilities, backed by extended service offered by experts in all fields of radiopharmaceuticals production. 16 17 PLUS PLUS ® ® I am a two IBA Cyclone® 18/9’s installations veteran! EXPERT SUPPORT TO Because of that, and throughout more than 12 years STAY AHEAD OF TIME

IBA // INTEGRALAB hands-on, I have experienced that the kind of professional, IBA // INTEGRALAB expertise and personal relationships can only be formed EXTENDED EQUIPMENT UPGRADE SUPPORT USERS MEETINGS through our active presence and participation at IBA user SERVICES meetings events. This is also the place where we learn from à Upgrade support for new à IBA holds worldwide customer other IBA user’s know-how. à Extended service contracts post- molecules, including equipment meetings warranty, including preventive and consumable selection, Dr. Mario Avila M.Sc., Ph.D., maintenance for all the equipment documentation and regulatory à Opportunity to meet other IBA Technologies and Production Manager to ensure maximum uptime year compliance users, exchange ideas and share Positron Pharma, Chile after year. experiences regarding operational à Upgrade-ready Cyclotron issues and new developments in ENDLESS INNOVATION configuration to offer an easy and the fields of cyclotrons, targetry à Open collaboration opportunities cost-effective upgrade at a later and chemistry. stage, if required. à Delivery of new tracers and à Learn about the curent & future automated production systems to trends in the radiopharmacy world. cover your R&D needs. EXPERT TO EXPERT, WORLDWIDE

The CAREprogram provides continuous Our products and services have been support in furthering your skills and designed from the experience we have applications, boosting your uptime and gathered in helping our clients to improve maximizing the return on your investment their business performance through with all the latest innovations, services customer satisfaction and loyalty. and training.

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PLUS INTEGRALAB PLUS ® ACHIEVEMENTS ® IBA has accomplished a ®

IBA // INTEGRALAB large number of IntegraLab IBA // INTEGRALAB projects worldwide.

Alkmaar, Almaty, Amman, Ankara, Astana, Baku, Bandar Enstek, Bangalore, Beijing, Beirut, Bern, Brisbane, Brunei, Brussels, Caracas, Coimbra, Dammam, Delhi, Dinnington, Fleurus, Ghent, Gilroy, Gliwice, Guilford, Guilin, Hanoi, Harvehill, Helsinki, Hengyang, Herlev, Jakarta, Kansas City, Karachi, Krasnoyarsk, Kien Giang, Kuala Lumpur, La Habana, Lahore, Memphis, Mexico, Minsk, Montreal, Moscow, Mount Pearl, Paris, Philadelphia, Porto Allegre, Rabat, Recife, Riga, Rio Negro, Rio Gallegos, Riyad, Romeoville, Rostov, Sandford, Santiago, Santo Domingo, Sevilla, Somerset, Sterling, Sydney, Teneriffe, Toronto, Tripoli, Tunis, Waghodia, Xiamen, Yangon,Yerevan, Zagreb... www.iba-integralab.com development ofRadiopharmaceutical IntegraLab Production Centers. compounds ( IntegraLab ABOUT INTEGRALAB experience insettingupGMPradiopharmaceuticals production centers. addition tohigh-qualitytechnologyproduction equipment,IBAhasdeveloped in-depth fromproviding project designtotheoperation themglobalsolutions, oftheirfacility. In radiopharmaceutical withtheirin-house radioisotopes distributioncenters production by Based onlongstandingexpertise, IBARadioPharma Solutionssupportshospitalsand ABOUT IBARADIOPHARMASOLUTIONS including IBA’s leadingfully-integrated IntegraLab that provide andequipment, oncologycare withpremium qualityservices providers the development ofnext-generation proton therapy technologiesandradiopharmaceuticals worldwide technologyleaderinthefieldofproton therapy. Thecompany’s expertise liesin isacancer diagnosticsandtreatment company andthe IBA (IonBeamApplications S.A.), ABOUT IBA IBA Group Tel.: +3210201275|Fax: +3210475958 |[email protected] Chemin duCyclotron, 3|1348Louvain-la-Neuve, Belgium CONTACT US: market isdesignedtoaccommodateawiderange processes. ofradiochemistry Synthera goals. installation ofsuitablehigh-technology equipmenttomatch your radioisotope production complianceandtheselection,integration, supplyandbuilding designedwithfullregulatory | IntegraLab ® + isamulti-purposeautomatedsynthesizer for theproduction of ® is a fully integrated solution combining equipment and services for isafullyintegrated the solutioncombiningequipmentand services 18 FCH, ® PLUS March 2017©IBA