Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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52 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Standards M anufacturers, regulators, and other industry orga- nizations are aiming to advance biopharmaceutical continuous manufacturing (BCM). The United States Pharmacopeial Convention (USP), a nonprofit organi- zation known for developing standards for quality, is actively involved in facilitating implementation of continuous manufacturing (CM) in the bio/pharmaceutical industry. "USP is uniquely qualified to convene all types of stakeholders to investigate challenging topics and, where suitable, move important initiatives into its robust, transparent, standard setting process," explains John Kokai-Kun, director, External Scientific Collabora- tion at USP. "Our solutions to help advance the understanding of specific quality attributes of new technologies are an important part of the overall safety net for medicines that build patient and provider trust." USP held its first Biologics Stakeholders' Forum on innovative pro- cess analytical technologies and digital technologies in August 2020, and participants discussed topics such as regulatory risk, business case, comparability, proprietary vs. open-source software, common terminology, and existing efforts in these areas, explains Kokai-Kun. Additional industry discussions since then have been ongoing. Phar- maceutical Technology spoke with Kokai-Kun about these efforts. Challenges PharmTech: What are some of the challenges in continuous processes? Kokai-Kun (USP): There are several challenges to implementing BCM processes, including technical ones. While continuous perfusion Facilitating Biopharma Continuous Manufacturing Jennifer Markarian Although advances have been made in continuous upstream biopharmaceutical processing as well as in some downstream operations, fully continuous operations that connect upstream and downstream are more challenging. USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing. RAWPIXEL.COM - STOCK.ADOBE.COM

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