Abstract
The challenge of how to demonstrate that a manufacturing process change does not impact the safety (immunogenicity) and/or the efficacy (potency) of the biologic will be examined. The three major factors that drive the design of a comparability study will be stressed: (1) risk-based (major, moderate, and minor changes), (2) sequential (analytical, nonclinical, and clinical), and (3) clinical phase-appropriate (early-stage clinical vs. later-stage clinical development). The difference between a comparability study and a comparability protocol will be discussed. Finally, in this chapter, demonstrating biologic comparability after a process change both within a manufacturer’s operation (i.e., comparability pre-change vs. post-change product) and between two different manufacturers (i.e., biosimilarity) will be compared.
The best laid schemes of mice and men go often askew…
Robert Burns, Scottish poet, from his poem
“To a Mouse, On Turning Up Her Nest With a Plow” (1785)
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Geigert, J. (2013). Demonstrating Product Comparability. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_12
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