ABSTRACT
To be successful, many factors should be considered when selecting, optimizing, and validating analytical test methods and in using test results to establish appropriate specifications for the product. Current regulatory guidance documents and several biotechnology industry publications available online give considerable information on the typical analytical methods used with different types of WCBPs and other biological products and current expectations for product characterization, release, and stability testing. For biotechnology product QC release testing, it is expected that orthogonal analytical methods will be used for key product attributes. Forced degradation studies provide critical information on the inherent stability of the product and its degradation pathways and confirm the capabilities and suitability of the analytical methods to be used in stability testing. But unlike chemical pharmaceutical products, expiration dates and retest periods for biological/biotechnological products cannot be determined from extrapolation of short-term results, but can only be established through real-time stability studies.
