Biopharmaceutical drugs are increasing in sophistication, requiring technological advancements to solve related challenges. The contributors to this BPI eBook highlight drug-product formulation concerns and collaborative efforts toward solving the fill–finish conundrum.
First, the BioPhorum’s Scott Ewan describes a holistic approach to container–closure integrity and the organization’s work toward developing and expanding upon that approach. Ewan explores how advancing analytical technologies, risk management, and quality by design (QbD) are changing the strategies related to container–closure integrity, which remains a significant aspect of product safety and stability.
Then, authors from Neurelis highlight the difficulties faced by companies developing biopharmaceuticals for nasal delivery, featuring a promising solution for the key problem of absorption. They also point out difficulties with a familiar type of excipient: polysorbates, which have been common to drug-product formulation for many years. But recent studies show that they can degrade to cause aggregation and particle formation. In nasal delivery systems, polysorbates provide no assistance for solving the absorption problem, but alkylsaccharides can — without the aggregation side effects.
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Scott Ewan is a facilitator with BioPhorum, The Gridiron Building,1 Pancras Square, London, N1C 4AG, United Kingdom; https://www.biophorum.com.
Stuart Madden is chief scientific officer at Neurelis, Inc., 3430 Carmel Mountain Road, San Diego, CA 92121; [email protected]. Edward T. Maggio, PhD, is cofounder, president, and chief executive officer of Aegis Therapeutics (part of Neurelis), 11770 Bernardo Plaza Court #353, San Diego, CA 92128; [email protected].
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