Articles
A Survey Of Bioassays In The Biopharmaceutical Industry
September 3, 2009
•Article: A Survey Of Bioassays In The Biopharmaceutical Industry
By C. Jane Robinson, Laureen E. Little, E. Clare Robinson, and Hans-Joachim Wallny
Bioassays represent a major investment in development, production, and licensing of most biopharmaceuticals. They present unique issues compared with physicochemical analytical techniques in their susceptibility to variables that may be difficult to identify or control.
Biological assays, especially potency assays needed to release product, are often poorly understood and greatly feared. Companies therefore tend to initiate their development too late and without a clear idea of how each assay should be used and formatted. Compounding these problems is the current lack of regulatory guidance.
Reprinted with permission from BioProcess International 4(6):24-36 (June 2006)
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