Issue link: https://www.e-digitaleditions.com/i/1462272
www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 37 Standards Facilitate Continuous Manufacturing USP discusses standards for biopharmaceutical continuous manufacturing processes. A lthough the biopharmaceutical manufactur- ing industry has made significant progress in implementing process intensif ication, including upstream continuous processing as well as in some downstream operations, fully continuous operations that connect upstream and downstream are more challenging. Manufacturers, reg- ulators, and other industry organizations are aiming to advance biopharmaceutical continuous manufacturing. The International Council for Harmonisation (ICH) published a draft guidance on continuous manufacturing (CM) in July 2021 (1) that was beneficial for both small-molecule drug manufacturing and biologic drug manufacturing, especially because it represents a consensus view of major global regulatory bodies. The United States Pharmacopeial Convention (USP), a nonprof it organization known for developing standards for quality, is actively involved in facilitating implementation of continuous manufacturing in the bio/pharmaceutical industry. " USP is uniquely qua lif ied to convene a l l t y pes of stakeholders to investigate challenging topics and, where suitable, move important initiatives into its robust, trans- parent, standard setting process," explains John Kokai- Kun, director, External Scientif ic Collaboration at USP. "Our solutions to help advance the understanding of spe- cific quality attributes of new technologies are an import- ant part of the overall safety net for medicines that build patient and provider trust." USP held its f irst Biologics Stakeholders' Forum on innovative process ana ly tica l technologies and digi- tal technologies in August 2020, and participants dis- cussed topics such as reg u lator y risk , business case, JENNIFER MARKARIAN Quality and Regulatory Sourcebook Compendial Compliance Rawpixel.com - Stock.adobe.com