Participants in a 2003 PhRMA workshop present the industry’s current thinking on developing analytical method equivalency, including the importance of sample selection, acceptance criteria, data evaluation, and documentation.
The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.
Rapidly increasing cell-culture yields have thrown an increasing burden on downstream processes just as price pressures are pushing process developers to look for economies in every purification protocol. The time-honored, effective, and expensive war-horse, Protein A, is beginning to feel some competition from small-molecule mimetics.