1. Plasma Fractionation Process Design
We provide complete design and engineering solutions for plasma fractionation plants, covering each stage from plasma collection to purified protein formulations. Our expertise includes both traditional Cohn fractionation and modern hybrid purification technologies.
Cohn Cold Ethanol Fractionation
The foundation of plasma fractionation, developed by Dr. Edwin Cohn, separates plasma proteins using controlled ethanol concentration, temperature, and pH.
Each fraction yields a different therapeutic protein:

• Fraction I: Fibrinogen

• Fraction II/III: Immunoglobulins

• Fraction V: Albumin

We ensure precise thermodynamic control, solvent handling safety, and continuous process improvement for maximum yield and purity.

2. Cryoprecipitation Process
Used to extract Factor VIII, fibrinogen, and von Willebrand Factor, this process involves thawing plasma at ~0°C and isolating cryoprecipitate through controlled centrifugation. The resulting material is essential for hemophilia and bleeding disorder treatments.

3. Chromatographic Purification
Chromatography enhances protein recovery and purity through ion-exchange, affinity, and size-exclusion techniques. We integrate these systems to improve resolution, throughput, and viral safety, replacing or complementing ethanol fractionation.

4. Hybrid Fractionation Systems
Our hybrid approach combines Cohn fractionation with advanced chromatography, nanofiltration, and pasteurization steps to ensure:

• Maximum purity and viral safety

• Efficient protein recovery

• Full compliance with EMA, FDA, and WHO standards

Key integrated technologies:

• Tangential Flow Filtration (TFF)

• Nanofiltration for virus removal

• Solvent/Detergent Treatment

• Pasteurization for viral inactivation

• Lyophilization for product stability
   

5. Facility Design and Engineering
We design and execute turnkey plasma fractionation facilities, balancing GMP compliance, efficiency, and scalability.
Key design features include:

• Unidirectional material & personnel flow

• Clean/dirty corridor separation

• Explosion-proof ethanol recovery systems

• Cold chain storage (-30°C)

• Modular or stainless-steel process areas

• Automation with digital validation systems
   

6. Process Equipment Integration
We specify and integrate all essential plasma processing equipment:

• Plasma Bag Openers

• Fractionation & Purification Vessels

• Centrifuges & Filter Presses

• Pasteurizers & Freeze Dryers

• Formulation & Fill-Finish Units (RABS integrated)

• CIP/SIP systems for automated cleaning

All systems are validated, automated, and connected to MES/SCADA for complete traceability and process control.