June 6-11, 2010
Getting a BLA approved for a new vaccine can be a daunting task, but keeping the market supplied after licensure of a successful vaccine can be an even bigger challenge. Analytics can play an important role in keeping product supplied to the marketplace, especially during the critical launch phase The talk will describe the application of analytical comparability to GARDASIL®, Merck’s novel new vaccine to prevent cervical cancer, in order to bridge product produced by a launch facility to that produced by a scale-up facility without the need for a clinical trial. This effort assured a smooth transition of supply and fulfilled marketing needs during the critical catch-up market phase for this product. Analytical tools are also important to sustain the market for older vaccine products which have been licensed for decades. In this case, the issues involved in modernization of the release methods will be discussed. Of particular note will be the special issues for bridging potency assay procedures for legacy products.
Robert Sitrin, "AFTER THE LICENSE APPROVAL: HOW ANALYTICS CAN KEEP YOU IN THE MARKET" in "Vaccine Technology III", John G. Auniņš,Merck, USA; Barry C. Buckland, BiologicB, USA; Kathrin U. Jansen, Pfizer, USA; Paula Marques Alves, IBET, Portugal Eds, ECI Symposium Series, (2010). http://dc.engconfintl.org/vaccine_iii/8