BioWorld International Correspondent

BRUSSELS, Belgium - Biotechnology experts at the European Medicines Evaluation Agency said that improved inactivation/removal steps for viruses are still needed for all plasma-derived medicinal products.

They recommended that all new measures to improve viral safety of blood products should be assessed in terms of their potential impact on efficacy, overall safety and supply. The findings of a specialized biotechnology working party have just been endorsed by the agency's key scientific body, the Committee for Proprietary Medicinal Products.

The working party reviewed the EMEA's 1995 guidance on plasma-derived medicines, and updated it to take into account recent developments in virus inactivation/removal methods and in nucleic acid amplification technology for blood-borne viruses. Information should be provided by the product manufacturer on the effectiveness of the process for the inactivation/removal of viruses, and should appear in the product's data sheet, the summary of product characteristics, as it is termed in the European Union.

The EMEA is insisting that effective inactivation/removal steps for the hepatitis A virus need to be implemented for all coagulation factor products and, where possible, these methods should be applied to other plasma-derived medicines. But the current methods to inactivate or remove hepatitis A virus are generally not suitable for immunoglobulins and solvent- or detergent-treated plasma, and new methods are needed.

While parvovirus B 19 is still difficult to inactivate or remove by current methods, some approaches can achieve limited inactivation or removal, and nucleic acid amplification technology testing of minipools for parvovirus B 19 can be used to reduce the viral load in manufacturing pools, the EMEA said. And as a priority, it said, inactivation and removal steps should be introduced in the manufacturing process, along with complementary measures such as nucleic acid amplification technology testing, to improve viral safety with respect to parvovirus B19, and for anti-D immunoglobulin, since it is used in a high-risk patient group.

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