Drug Regulators FDA publishes Guidance on Nucleic Acid Testing (NAT) to reduce the possible risk of Human Parvovirus B19 Transmission by Plasma-Derived Products.
A full copy is available here. Europe has also been beefing up its regulations in this area, article 1, article 2.
Introduction
The FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to FDA implementation of parvovirus B19 NAT.
Background
Human parvovirus B19 is a small, non-enveloped single stranded DNA virus. Virus clearance studies, using non-human parvoviruses as models for parvovirus B19, have indicated that this virus is highly resistant to all commonly used inactivation methods, including heat and solvent/detergent (S/D) treatment, and is also difficult to remove by filtration because of its small size. More recent studies have demonstrated that human parvovirus B19 may be more readily cleared than certain model animal parvoviruses. The parvovirus B19 can be transmitted by blood components and certain plasma derivatives, and may cause morbidity to susceptible recipients such as pregnant women (and their fetuses exposed in utero), persons with underlying hemolytic disorders, and immune compromised individuals.
Recommendations
We recommend that you implement the following procedures to detect the presence of parvovirus B19 DNA:
- For all plasma-derived products, you should perform parvovirus B19 NAT as an in-process test to ensure that the viral load of parvovirus B19 DNA in the manufacturing pools does not exceed 10×4 IU/mL.
- Use parvovirus B19 NAT on minipool samples to screen plasma units intended for further manufacturing into plasma-derived products. Primers and probes selected for parvovirus B19 NAT should detect all known genotypes of the virus.
- When identified, you should not use individual plasma units, intended for further manufacturing into plasma-derived products, when such units are found to have a titer of parvovirus B19 DNA that might result in plasma manufacturing pools exceeding a parvovirus B19 DNA titer of 10×4 IU/mL.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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