Rapid Manufacture and Release of a GMP Batch of Avian Influenza A(H7N9) Virus-Like Particle Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology

by Timothy J. Hahn, PhD, Denise Courbron, Mervyn Hamer, Malek Masoud, James Wong, Konnie Taylor, Jody Hatch, Mike Sowers, Erica Shane, PhD, Margret Nathan, Hua Jiang, PhD, Ziping Wei, PhD, John Higgins, Kwan-Ho Roh, John Burd, Diana Chinchilla-Olszar, PhD, Monique Malou-Williams, Daniel P. Baskind, and Gale E. Smith, PhD
Volume 12, Issue 2 (Summer 2013)

Novavax reported that, in 28 days following public release of the avian influenza A/Anhui/1/2013 (H7N9) virus gene sequences, its recombinant DNA and baculovirus-Spodoptera frugiperda cell culture-based technology was used to produce a virus-like particle vaccine to avian influenza A(H7N9) virus, and murine animal challenge studies were initiated. This report describes Novavax’s manufacturing process and the coordinated timing of critical activities necessary to produce and release a clinical batch of avian influenza A(H7N9) virus virus-like particle vaccine, under current good manufacturing practices, within three months from the time that the virus genomic sequences for this potential pandemic influenza virus were reported...

Citation:
Hahn TJ et al. Rapid Manufacture and Release of a GMP Batch of Avian Influenza A(H7N9) Virus-Like Particle Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology. BioProcess J, 2013; 12(2): 4-17. http://dx.doi.org/10.12665/J122.Hahn.

Posted online July 29, 2013.