Safety issues for plasma derivatives and benefit from NAT testing

Area of Science:

• Biotechnology
• Virology
• Pharmaceutical Manufacturing

Background:

• Plasma derivative manufacturing effectively inactivates enveloped viruses (HIV, HCV, HBV).
• Non-enveloped viruses, particularly Parvovirus B19 (B19), pose a challenge due to their heat resistance and small size.
• High viral loads in donations and manufacturing limitations create a residual risk of B19 contamination.

Purpose of the Study:

• To evaluate the effectiveness of manufacturing processes for plasma derivatives regarding virus removal.
• To highlight the challenges in eliminating non-enveloped viruses, specifically Parvovirus B19.
• To assess the role of Nucleic Acid Testing (NAT) in detecting and preventing viral contamination in plasma products.

Main Methods:

• Review of manufacturing processes for plasma derivatives.
• Analysis of virus inactivation and removal efficacy, focusing on enveloped vs. non-enveloped viruses.
• Evaluation of Nucleic Acid Testing (NAT) for virus detection in plasma donations and during manufacturing.

Main Results:

• Enveloped viruses are generally well-removed/inactivated, ensuring product safety for HIV, HCV, and HBV.
• Parvovirus B19 (B19) presents a significant challenge for removal/inactivation due to its properties and high contamination levels.
• Nucleic Acid Testing (NAT) is effective for detecting HCV-RNA and can be valuable for monitoring virus removal during manufacturing, especially for viruses lacking infectivity assays.

Conclusions:

• Plasma derivatives are safe from clinically significant enveloped viruses but carry a residual risk from non-enveloped viruses like B19.
• Nucleic Acid Testing (NAT) is a vital tool for enhancing the safety of plasma products by detecting and preventing contamination.
• Further validation of NAT for assessing virus removal during manufacturing is recommended, particularly for challenging viruses like B19.