Biopure
Plasma Collection and Fractionation Technology

Building the worlds most advanced Human Plasma Purification Facilities

Biopure innovates plasma fractionation for the future. With over 37 years of experience we have developed the safest and most efficient process for purifying plasma proteins for the manufacturing of life saving medicinal products. Avoid costly intermediate brokers for technology, assistance or the transfer of know-how. We supply all requirements for TURN-KEY projects from A to Z (process chemistry, engineering, validation, training, team integration and consulting services for a new project or expansion). We are the only company to deliver all requirements for turn-key projects and consulting. We focus on your requirements while integrating innovating technologies, developing time effective strategies and a design with cost saving scalable solutions.

Design, Build & Comission

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Comprehensive EPC Services

Need help planning, construction, procurement and supervision or auditing your next biopharmaceutical project? Let us guide you. Any organization can move forward with small incremental changes, but building for the future in today’s rapidly evolving environment means taking bold chances and making insightful decisions.

Introduction

Achieve Your Goals

We provide Consulting and Engineering, Procurement, Construction (EPC) services. We are responsible for all the activities from design, procurement, construction, commissioning and handover of the project to the end-user or owner

Strategic Planning Session

Expert Engineering and Design

With over 35 years of experience, our staff has the capabilities and expertise to take your business to the next level. At Biopure we combine our insights and skills to transform your processes and strategies, and in turn, your company. We’re proud to help shape and improve how our clients structure and manage their business.

Human Plasma Derived Products

Complete facility construction, engineering, technology transfer and regulatory approval for:

Immunoglobulins: Solvent Detergent (SD) inactivated and Nano-Filtered (NF), Liquid
Albumin: Heat Pasteurized 5%-20%-25%
Hyperimmune IgG: SD NF, Rabies, Tetanus, Anti-D
Factor VIII: SD and NF, freeze dried
Prothombin Complex: SD and NF, freeze dried
Factor IX: SD and NF, freeze dried
Fibrin Seal: SD, liquid frozen or freeze dried
Fibrinogen: SD and freeze dried
Alfa1 Anti-Trypsin: SD and freeze dried
Anti-Venoms: SD and virus inactivated, high purity and activity

Experience

Biopure: is the only firm to provide consultation services and design the 4 largest Human Plasma Fractionation Facilities in South America and Europe.

1. Purissimus: Argentina, 1980-2010. Full Project Implementation.

2. Hemasure: Denmark: 1984-1985: Large scale chromatography processes.

3. Cangene: Canada, 1985-1986. Chromatographic Anti-D purification.

4. Melville Biologics: USA, 1988-1989. Solvent Detergent virus inactivation

5. Massachusetts Dept Public Health: USA, 1991-1992 Liquid IgG formulation and purification.

6. Genbio: Mexico, 2010-2014. Full Project Implementation.

7. LFB: France, 2015-2017. Optimizing protein purification. Corrective actions regarding poor yields and contamination issues in albumin. Improvements in Clean in Place and Ultrafiltration Technology.

8. Hemobras: Brazil, 2014-2016. Training and technology transfer lei-son between LFB and Hemobras. WFI and CIP technology transfer. Engineering audits.

Building Fractionation Capacity

Process Scaling

Construct, Train, Validate and Commissioned with Regulatory Approved in <28 months.

Mini Bio-Pilot laboratory scale facility 1 to 5K Liters per year (new service)
Mini: 20K to 50K liters/year plasma
Midi: 50K to 250K liters/year plasma
Maxi: 250K to 1 Million liters/year plasma with 150K-300K Pre-installed upgrade capability
Mega: 2 to 5 Million liters/year plasma

Global Relations

Grow Your Business

We subscribe to strict confidential agreements with all of our clients. We have performed in 3 continents and have provided counseling for private, government and public heath institutions (Argentina, Bolivia, Paraguay, Peru, Colombia, Mexico, USA, Turkey, Denmark, Canada, Brazil, South Africa) We have collaborated with companies in various countries for approval of facility license and product registration. In the area of human plasma based therapeutic products we have aided in the development for plasma toll-fractionation contracts with several countries and assisted the supply human source and recovered plasma worldwide. In the area of plant management, we have successfully implemented command and control operations at all levels of staff organization for optimum facility operation. We have global experience in contract toll fractionation and sales, distribution and registration of plasma derivatives.

We Build Teams

People are the Success to our Projects

We train, educate and work hand in hand. We provide complete instruction at all levels of facility operation and quality control. We remain available for any future assistance 24/7 365 days a year.

Biopure exists to solve the critical issues facing our clients, both large and small, private or public. Our unique experience is not only what differentiates us, but also what makes us successful. We provide a broad range of services from small and large scaled solutions to help organizations facilitate change, achieve their vision and optimize performance and productivity. Plasma fractionation facilities only manufacture. Furthermore, fractionation facilities have neither the engineering skills, time, or infrastructure to build, validate and most importantly train personnel. Fractionator's have adopted or inherited an outdated industrial technological service thus to implement a new technology they would require to revalidate all processes. All fractionator's that have tired to build a plant for others have either failed or have run the projects into immense debts. Don't be fooled by the those that have never built a facility or claim to have managed one.