Pharma & Biotech processes: global turnkey solutions

Pharma & Biotech processes: global turnkey solutions

02 Our mission: to design and build turnkey process solutions AS A LEADING-EDGE INDUSTRIAL INTEGRA- TOR, BOCCARD DESIGNS AND BUILDS UNIQUE PHARMACEUTICAL AND BIOTECHNOLOGY LABORATORIES THAT FACILITATE THE PRO- DUCTION OF ALL LIQUIDS AND SEMI-LIQUID FORMS, GELS AND CREAMS. BOCCARD IS THE INDUSTRIAL INTEGRATOR THAT BRINGS YOUR PROJECTS TO LIFE ON TIME AND ON BUD- GET. AT BOCCARD, WE UNDERSTAND THE IM- PORTANCE OF «TIME TO MARKET» REQUIRE- MENTS. OUR COMMITTMENT TO QUALITY AND PERFORMANCE MEANS BOCCARD ALWAYS DE- LIVERS PROCESS SOLUTIONS THAT ARE CARE- FULLY DESIGNED TO MEET OUR CUSTOMERS VARIED DEMANDS AND SPECIFICATIONS. BOCCARD MANAGES EACH AND EVERY STAGE OF YOUR PROCESS DESIGN SOLUTION Biofermentation / Cell culture Media preparation / Solutions Formulation Separation / Clarification Purification / filtration / Chromatography Inactivation Cleaning-in-Place / Sterilization-in-Place Decontamination

03 With agencies and subsidiaries in more than 30 countries, Boccard has an outstanding ability to assist your company s worldwide expansion. We value long-term partnerships and, working with our international team of skilled, multidisciplinary project leaders, engineers and technicians, Boccard applies an unrivalled level of knowledge and expertise. Boccard supports your production processes by providing a single contact person who manages your project from launch through to delivery. Through the rigorous application of internationally-established best practice policies, Boccard guarantees that your project will be managed in a responsive manner and to a high degree of certification, in line with our PQP charter and manual: «Prevention, Quality, and Productivity». STERILE LIQUIDS Eye and nasal drops Infusion solutions Antibiotics Vaccines Injectable liquids Insulin Therapeutic proteins Monoclonal antibodies (mab) Plasma derivatives: - Albumin - Immunoglobulin - Factor VIII, Factor IX Because we are able to integrate the best process equipment, selected jointly with you, Because we know how to do so within very short timeframes, within budget, and anywhere in the world, Because we design fully open and independent automated procedures for your project, Boccard is the ideal partner for turnkey new plant, technology transfer, plant extension and GMP standard compliance projects. DRINKABLE FORMS Syrups GELS & CREAMS Hand sanitizer gels Ointments Suppositories

04 Global, high-performance solutions that bring your ideas to life REALIZING YOUR IDEAS From the very beginning of any project, our process engineers are dedicated to implementing your vision in line with the strictest international regulatory requirements. Our determination to meet the highest market expectations means Boccard provides a performance guarantee - we ensure your project remains within budget and responds to your exact deliverables. Boccard: Experts in Project Management Always on time, Always on spec, Always on budget. WITH OUR PROVEN SOLUTIONS All our skids undergo comprehensive static and dynamic testing on our test platforms. Boccard s extensive experience across a vast range of pharmaceutical facilities significantly benefits your business; having accumulated over 20 years industry expertise, we use our wide-ranging knowledge to ensure your project is equipped with high-performance, high-tech production lines and skids. «We chose Boccard/CSC for our Biotechnology plant in Brazil because we wanted an industrial integrator that was able to deliver a turnkey facility and provide us with a performance guarantee. We were particularly impressed with their expertise in the boiler-making sector. As a company that works with plasma derivatives, we have extremely precise requirements.» S.J., Hemobras Project Manager, LFB Sls ATEX ABSOLUTE CERTIFICATION CONFIDENTIALITY: NDA FOR SHARED SUCCESS We bring together the skills that guarantee you the best performance at each key stage of your process. Our specialists always seek out the most innovative technical solutions for fermentation, filtration and separation etc. We optimize the quality of your products, allowing you to deliver the best possible results for your end customers. BOCCARD ALSO OFFERS A range of innovative solutions to simplify your production processes: PPM Chromatography PPM Ultrafiltration PPM Bioreactor/Biofermenter PPM Block for the elimination of dead volumes Boclock, the intelligent process connector Pharmaloop water loop for PW/WFI

05 Turnkey technology transfer solutions BOCCARD IS A KEY INTERNATIONAL DESIGNER AND SUPPLIER OF INDEPENDENT MODULAR SKIDS, MODULAR SUPER-SKIDS AND SUPERIOR QUALITY PRODUCTION PLANTS. AT BOCCARD, OUR SUPERB LEVEL OF WIDE-RANGING EXPERTISE ALLOWS US TO BRING TOGETHER INNOVATIVE TEAMS OF EXPERIENCED PROFESSIONALS. THIS EXPERTISE DRIVES THE SUCCESS OF YOUR PROJECT! ASSISTING YOU WORLDWIDE Boccard - Providing a Truly International Perspective Having completed projects throughout Europe, as well as in Pakistan, Egypt, Malaysia, Russia, Brazil, Argentina and Algeria, Boccard has become a globally-recognized industrial integrator. Our knowledge of the field combined with our project management expertise allows Boccard to bring together the services of qualityfocused local subcontractors in various international locations. This approach provides Boccard clients with optimal, cost-effective solutions. Our teams are fullyproficient in relevant industry codes and certifications such as ASME BPE, DESP, GMP, FDA etc. CONSTRUCTION MODELING To ensure effective communication, Boccard has established a unique design office that acts as a platform for collaboration and project review - a system that is based on the 3D modeling of part (or all of) your plant and of the projected facilities. This way, you can view your production tools before they are built. SUPPLY CHAIN CONTROLS Boccard - Implementing Efficient Project Management Methodologies Because the success of every project also depends on logistics, Boccard guarantees the timely delivery of on-site equipment, even in unstable political or cultural environments. We provide reliability for your project by prefabricating the modules and seeking your approval for the designs and ergonomics prior to installation. Thanks to our international agency network, we can then build these modules in workshops located throughout the world.

06 Resources and manpower: a synergy of skills to deliver guaranteed success PROCESS ENGINEERING EXCELLENCE For full integration of your manufacturing process, Boccard offers excellence in engineering; we combine superior project management knowhow with the flexibility and creativity of a LEAN, customized design. We are dedicated to providing guaranteed performance and support both during and after project implementation. MAJOR MOBILIZATION CAPACITY The team you work with during the project is the same one that commissions your facility. Boccard is the only industrial integrator capable of mobilizing a start-up team featuring several dozen automation specialists, technicians, and engineers. With our in-depth knowledge of the process and operations of your facility, we are able to ensure that you receive the best possible start-up service, including SAT tests and IQ/OQ qualification. QUICK, INNOVATIVE E-QUALIFICATION We use a unique paperless qualification documentation system to: - monitor commissioning tests (FAT-SAT) in real time for projects deployed throughout the world - optimize non-conformity management - facilitate and speed up reporting processes (review workflow, protocol approval, customer reports) - standardize test progress sheets (protocols) based on real, non-subjective data. YOUR PROCESS: FULLY CONTROLLED Our engineers design fully-open automation systems that are compatible with several of the major solutions currently available (Siemens, Rockwell, Emerson, Wonderware, etc.). We involve your teams in the design and ergonomics of the control system, as well as providing training using our simulation platforms.

07 Our expertise in the downstream process: protein purification BUILDING ON OUR EXPERIENCE IN THE BIOTECH AND PHARMACEUTICAL SECTORS, WE HAVE DEVELOPED A NEW HIGH-TECH RANGE OF PPM, SEPARATION AND PURIFICATION SOLUTIONS TO ISOLATE HIGH VALUE- ADDED PROTEINS (VACCINES, INSULIN, MAB, AND PLASMA DERIVATIVES). OUR RANGE OF SOLUTIONS Crossflow ultrafiltration skid Nanofiltration skid Chromatography skid KEY BENEFITS Compact, modular, CIP/SIP performance, flexible and intuitive automation system with acceptance-testing system and traceability, precision. Our new range covers both laboratory and industrial production flow rates. It also works with our latest-generation dilution-in-line system (up to 50 times concentration), allowing you to reduce the size of your buffer tanks. Because every drop counts, we have designed and patented new valve blocks (PPM Block) and instruments to eliminate dead volumes.

BOCCARD S.A. Health & Beauty Department 158 avenue Roger Salengro - BP 36080 69604 VILLEURBANNE CEDEX - France Tél : + 33 4 37 28 12 00 Fax : +33 4 37 28 12 05 Contact : pharmaceutical@boccard.com www.boccard.com - Boccard has a presence in more than 30 countries worldwide - Conception / photos : Boccard - Thinkstock