Article ID Journal Published Year Pages File Type
2487623 Journal of Pharmaceutical Sciences 2007 12 Pages PDF
Abstract
In the biotechnology area, the issue of comparability with an innovator product is complex. Ideally, a side‐by‐side 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 follow‐up 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 “out‐of‐process” protein. © 2007 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 96: 3214-3225, 2007
Related Topics
Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Drug Discovery
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