CBER Draft Guidances for Spore-Formers and Plasmid Vaccines

The US Food and Drug Administration Center for BiologicsEvaluation and Research (CBER, Rockville, MD, www.fda.gov/cber) issuedtwo draft guidance documents during the past week.

The 19-page ManufacturingBiological Drug Substances, Intermediates, or Products UsingSpore-Forming Microorganisms. appeared on Feb. 23. The draftupdates CBER guidance to conform with the rule, Revision of the Requirements forSpore-Forming Microorganisms, which went into effect June 1,2004. The proposed guidance covers containment, procedural controls,waste disposal, campaign changeovers, sampling and testing, spillcontainment, maintenance, and decommissioning of dedicated and thenewly authorized multi-product facilities.

The 10-page Considerations forPlasmid DNA Vaccines for Infectious Disease Indications, issuedFeb. 17, updates the December 1996 "Points to Consider on Plasmid DNAVaccines for Preventive Infectious Disease Indications." In addition toR&D topics, the draft proposes guidelines for manufacturing this unfamiliar class of products. (The guidance defines plasmid DNAvaccines as "purified preparations of plasmid DNA designed to containone or more genes from a pathogen as well as regulatory geneticelements to enable production in a bacterial host system." The pureplasmids are injected into the body, where they are taken up by thepatient's cells and begin producing antigen, which stimulates an immuneresponse.) The draft guidance outlines which elements of themanufacturing  process must be described in the InvestigationalNew Drug Application, and the release-testing components CBER willexpect for bulk plasmid product release and final release.

-Douglas McCormick