Pharma & Biotech processes:

global turnkey solutions

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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.

Biofermentation / Cell culture

Media preparation / Solutions

Formulation

Separation / Clarification

Purification / filtration / Chromatography

Inactivation

Cleaning-in-Place / Sterilization-in-Place

Decontamination

Our mission:to design and build

turnkey process solutions

BOCCARD MANAGES EACH AND EVERY STAGE

OF YOUR PROCESS DESIGN SOLUTION

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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

DRINKABLE FORMS

Syrups

GELS & CREAMS

Hand sanitizer gels

Ointments

Suppositories

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».

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,

Because we are able to integrate the best process

equipment, selected jointly

with you,

Boccard is the ideal partner

for turnkey new plant, technology transfer,

plant extension and GMP standard

compliance projects.

ATEX CERTIFICATION

ABSOLUTE CONFIDENTIALITY:

NDA

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 SOLUTIONSAll 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.

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.

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« 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

Global, high-performance solutions that bring your ideas to life

BOCCARD ALSO OFFERSA 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

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.

ASSISTING YOU WORLDWIDEBoccard - 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 quality-focused local subcontractors in various international locations. This approach provides Boccard clients with optimal, cost-effective solutions. Our teams are fully-proficient 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.

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!

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Turnkey technology transfer solutions

BOCCARD IS A KEY INTERNATIONAL DESIGNER AND SUPPLIER OF INDEPENDENT MODULAR SKIDS, MODULAR SUPER-SKIDS AND SUPERIOR QUALITY PRODUCTION PLANTS.

Resources and manpower: a synergy of skills to deliver

guaranteed success

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YOUR PROCESS: FULLY CONTROLLEDOur 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.

MAJOR MOBILIZATION CAPACITYThe 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.

PROCESS ENGINEERING EXCELLENCEFor full integration of your manufacturing process, Boccard offers excellence in engineering; we combine superior project management know-how 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.

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.

Crossflow ultrafiltration skid

Nanofiltration skid

Chromatography skid

Our expertise in the downstream process:

protein purification

OUR RANGE OF SOLUTIONS

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).

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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.

KEY BENEFITS

BOCCARD S.A.Health & Beauty Department

158 avenue Roger Salengro - BP 3608069604 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 -

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