Pharmaceutical NEWS - Spring 2010

FDA issues new guidance on viral vaccines

by Dr. Kate Bergmann, manager of viral safety and viral clearance

Virus vaccines are produced in cultured cells, usually of human or animal origin. Cell lines and viral seed material could contain contaminants whose presence is undesirable in the vaccine. Whole virus vaccines are often only minimally processed after being harvested from cell culture, and it is not usually possible to validate the process for clearance of adventitious agents. Therefore, the strategy for ensuring safety and purity of vaccines relies heavily upon comprehensive testing and qualification of starting materials, along with lot-by-lot testing for adventitious agents.

Previously, there was no FDA guidance specifically for viral vaccines, but recommendations were included in several different regulatory documents. The FDA issued draft guidance on vaccines in 2006. In February 2010 the FDA issued the final guidance, regarding the characterization and qualification of material used for the production of viral vaccines for human use. This document describes recommendations for selection of a cell substrate, production and characterization of cell banks, production and characterization of viral seeds, and selection and characterization of biological raw materials. It describes tests and testing procedures to be used for each material and each stage of production.

Lancaster Laboratories provides testing services to support virus vaccines. Contact us to discuss your needs at 717-656-2300.

Link: "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications"