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12 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com A biopharmaceutical or biotech innovator's knowledge and understanding of a manu- facturing process is gradually built during the activities that lead up to the product's commercialization. FDA's 2011 process validation guid- ance (1) advises that a lifecycle approach should be tak- en as the product progresses through clinical trials and approaches potential commercial approval. This pro- cess incorporates three stages of process design, pro- cess qualification, and continued process verification. With each process designed and built using these three stages, knowledge accumulated will then inform the approach for subsequent product commercialization. The first stage of process validation is process de- sign, which incorporates the development, defini- tion, and characterization of the process. This stage is supported by a systematic and comprehensive risk assessment and includes elements of quality by de- sign (QbD). The main outcome of this stage is a clear understanding of the manufacturing process for a product, including each element required to define its control strategy. The control strategy, in turn, sets the foundation that ensures product quality is maintained throughout its manufacture. It is approved before pro- cess performance qualification (PPQ) "at scale" and is maintained as a living document throughout the life- cycle of the product. The second stage, process qualification, begins with PPQ and certifies that the product is being made con- sistently, with the required quality, and with support- ing documentation. Stage three, which is continued process verifica- tion, monitors the manufacturing to ensure that the expected quality continues to be confirmed each time that the product is manufactured, and that the process remains robust. Streamlining and Standardizing Process Characterization Claudia Berdugo- Davis, PhD, is director of Process Development, Catalent Biologics. Danielle Wittenwyler, PhD, is manager, Manufacturing Science & Technology, Catalent Biologics. Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks. MONSTER ZTUDIO - STOCK.ADOBE.COM