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Viral infectivity of albumin and plasma protein fraction
1Department of Pharmacy Practice, College of Pharmacy, University of Arizona, Tucson 85721, USA.
Abstract:
Original research, reviews, and case reports discussing viral infectivity of blood- and plasma-derived products were reviewed to determine the potential viral infectivity of human serum albumin (HSA) and plasma protein fraction (PPF). Data concerning viral infectivity viral screening and inactivation procedures, and viral outbreaks associated with blood and plasma products were extracted and evaluated for pertinence to HSA and PPF. The starting material used for fractionation, the manufacturing process, postmanufacturing handling, and immunocompetence of HSA or PPF recipients were assessed to determine risk of symptomatic viral disease after transfusion. Both HSA and PPF are manufactured with pasteurization procedures that have led to an excellent viral safety record based on 50 years of clinical use. One outbreak of hepatitis B was associated with PPF as a result of an unreliable manufacturing process that has been corrected. The pasteurization process is effective in eradicating known viral pathogens when good manufacturing practices are followed. Continued surveillance of such products is warranted for viruses not included in routine screening procedures and for those that are resistant to current inactivation methods.
Insights
Human serum albumin (HSA) and plasma protein fraction (PPF) demonstrate excellent viral safety due to pasteurization. While one hepatitis B outbreak occurred, manufacturing improvements ensure safety when good practices are followed.
Area of Science:
- Biologics Safety
- Viral Pathogen Inactivation
- Plasma-Derived Products
Background:
- Blood- and plasma-derived products carry potential viral risks.
- Assessing viral infectivity of human serum albumin (HSA) and plasma protein fraction (PPF) is crucial for transfusion safety.
Purpose of the Study:
- To evaluate the viral safety of HSA and PPF.
- To assess risks associated with their manufacturing and clinical use.
Main Methods:
- Systematic review of research on viral infectivity in blood products.
- Extraction and evaluation of data on viral screening, inactivation, and outbreaks.
- Assessment of manufacturing processes, handling, and recipient factors.
Main Results:
- HSA and PPF have an excellent viral safety record over 50 years, attributed to pasteurization.
- A past hepatitis B outbreak linked to PPF was due to manufacturing issues, now corrected.
- Pasteurization effectively inactivates known viruses when good manufacturing practices are maintained.
Conclusions:
- Current pasteurization methods provide robust viral safety for HSA and PPF.
- Ongoing surveillance is necessary for emerging or resistant viruses.
- Adherence to good manufacturing practices is essential for product safety.