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STABILITY PROGRAMS FOR BIOTECHNOLOGY PRODUCTS

This article was originally published in The Gold Sheet

Executive Summary

...may require a reassessment of development and early clinical materials to understand the significance of process, product and analytical changes made later, FDA and industry experts are cautioning. At a "CMC strategy forum" on biotech product stability, participants explored the intimate web of relationships between the analytical work done in the development phase and a viable stability program on the commercial product. Producing and retaining enough material during the earlier phases is among the ways firms must plan ahead if the program objectives are going to be achieved. Challenging issues for biotech products include: - how to set reasonable stability targets in the early clinical phases - the role of stability assessments in change control - the implications of non-conforming results, and - how to incorporate new information as assays improve. [Included are presentations from the stability strategy forum on the role of stress studies in the development process, setting up a stability program in the late clinical/application phase, and post-marketing issues].
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