Chiron Looks to Flu Vaccine Cell Culture; FDA Gears Up

November 17, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Chiron Looks to Flu Vaccine Cell Culture; FDA Gears Up

On Nov. 16, representatives from Chiron Corporation (Emeryville, CA, www.chiron.com) and Solvay Pharmaceuticals (Brussels, Belgium, www.solvay.com) were scheduled to address US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to support shifting influenza vaccine production from chicken eggs to canine kidney-cell cultures. FDA scientists supported the proposal, saying in briefing documents, "These cells offer significant advantages for routine influenza vaccine manufacturing, as well as being able to meet the unique challenges of pandemic vaccine manufacturing posed by virulent avian strain candidates,” according to an Associated Press Report.

Chicken-egg passaging has been the standard method of antiviral vaccine production for more than 60 years. Producing enough vaccine for a single season of immunizations in the United States requires some 80 million eggs and a process that must begin six months or more before the flu season starts. A switch to cell-culture systems could reduce the lead time from half a year to a few weeks, while shifting manufacturing into a much more tightly controlled process-a boon to vaccine makers who have suffered from batch contamination problems in traditional processes.

Earlier, on Nov. 10, new FDA Commissioner Andrew C. von Eschenbach announced the appointments of Boris Lushniak and Jeffrey Shuren to co-chair the agency’s Task Force on Pandemic Influenza. The Task Force will focus on promoting vaccine and antiviral production, and will involve members from 14 FDA centers and offices.

And, as of Nov. 14, FDA has approved the release of 150 batches of influenza vaccine for this flu season:

ManufacturerTrade NameTotal Number of Lots Released by FDA
Aventis-Pasteur Inc Discovery Drive Swiftwater, PA 18370-0187 (800) 720-8972 fax: 888-889-7129Fluzone91
Chiron Vaccines Ltd 4560 Horton Street Emeryville, CA 94608-2916 (510) 655-8730 fax: (510) 655-9910Fluvirin13
GlaxoSmithKline Biologicals 2301 Renaissance Blvd King of Prussia, PA 19406-2772 (610) 787-7000 fax: (610) 787-7777Fluarix22
MedImmune Vaccines, Inc 297 North Bernardo Ave Mountain View, CA 94043 877-358-6478FluMist18