Plasma fractionation issues

Area of Science:

• Biotechnology
• Biopharmaceutical Manufacturing
• Immunology

Background:

• Human plasma fractionation is a critical global industry supplying essential therapeutic proteins.
• Both private and public sectors contribute to the production of safe and effective plasma-derived medicines.
• Key products include immunoglobulins, albumin, and clotting factors (Factor VIII, Factor IX).

Purpose of the Study:

• To highlight the significance of human plasma procurement and processing for therapeutic protein production.
• To underscore the role of the bi-sector industry in meeting global demand for plasma-derived medicines.
• To emphasize the effectiveness of viral inactivation techniques in ensuring product safety.

Main Methods:

• Plasma collection and processing for fractionation.
• Purification of specific therapeutic proteins such as immunoglobulins, albumin, Factor VIII, and Factor IX.
• Application of viral inactivation/removal processes, including solvent detergent treatment.

Main Results:

• Successful fractionation yields essential therapeutic proteins for clinical use.
• Established viral inactivation methods effectively prevent the transmission of enveloped viruses like HBV, HIV, and HCV.
• A robust supply chain exists through both private and public sectors.

Conclusions:

• Human plasma fractionation is a vital multi-billion dollar industry.
• The dichotomous industry structure ensures a consistent supply of critical plasma-derived therapies.
• Robust viral safety measures are paramount and effective in protecting patients.