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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustryAnalytical Comparability and Similarity

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical... [In all manufacturing settings, there is an inherent drive to improve product through the reduction in process variation, implementing new technology, increasing efficiency, optimizing resources, and improving customer experience through innovation. In the pharmaceutical industry, these improvements come with added responsibility to the patient such that product made under the post-improvement or post-change condition maintains the safety and efficacy of the pre-change product. As described in FDA comparability guidance (1996) and ICH Q5E (2004), regulatory agencies also recognize the importance in providing manufacturers the flexibility to improve their manufacturing processes. Agencies also acknowledge that some changes may not require additional clinical studies to demonstrate safety and efficacy so that implementation may be more efficient and expeditious to benefit patients. Activities performed when changes are made to the process include demonstration of comparability in product parameters. The actual timing of each activity and the statistical rigor required for the evaluation of pre- and post-change product is linked to the stage of the product development (e.g., clinical versus commercial material) and the scope of the change (e.g., process transfer with similar scale versus a new cell line or formulation).] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustryAnalytical Comparability and Similarity

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing AG 2017
ISBN
978-3-319-50184-0
Pages
329 –369
DOI
10.1007/978-3-319-50186-4_9
Publisher site
See Chapter on Publisher Site

Abstract

[In all manufacturing settings, there is an inherent drive to improve product through the reduction in process variation, implementing new technology, increasing efficiency, optimizing resources, and improving customer experience through innovation. In the pharmaceutical industry, these improvements come with added responsibility to the patient such that product made under the post-improvement or post-change condition maintains the safety and efficacy of the pre-change product. As described in FDA comparability guidance (1996) and ICH Q5E (2004), regulatory agencies also recognize the importance in providing manufacturers the flexibility to improve their manufacturing processes. Agencies also acknowledge that some changes may not require additional clinical studies to demonstrate safety and efficacy so that implementation may be more efficient and expeditious to benefit patients. Activities performed when changes are made to the process include demonstration of comparability in product parameters. The actual timing of each activity and the statistical rigor required for the evaluation of pre- and post-change product is linked to the stage of the product development (e.g., clinical versus commercial material) and the scope of the change (e.g., process transfer with similar scale versus a new cell line or formulation).]

Published: Feb 17, 2017

Keywords: Accelerated stability; Analytical comparability; Analytical similarity; Biosimilar products; Comparability criterion; Equivalence testing; Non-profile data; Power calculations; Profile data; Scale comparisons; Stability data; Tolerance intervals

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