Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2487623 | Journal of Pharmaceutical Sciences | 2007 | 12 Pages |
Abstract
In the biotechnology area, the issue of comparability with an innovator product is complex. Ideally, a sideâbyâside comparison of physical properties would be part of the demonstration of comparability. However, biogeneric companies do not have access to the bulk drug substance from the innovator company for biophysical comparison, and isolation of protein from marketed product cannot be guaranteed to produce material that is identical to the bulk drug substance from which it was prepared. In a recently published study, protein was isolated from marketed product and comparative studies performed. In a followâup investigation of the published work, we demonstrate here that even a simple isolation procedure can significantly compromise the protein, which raises serious questions about the interpretation of that study, and in a broader context the value of any studies done with such “outâofâprocess” protein. © 2007 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 96: 3214-3225, 2007
Keywords
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
G.A. Heavner, T. Arakawa, J.S. Philo, M.A. Calmann, S. LaBrenz,