Biomanufacturer Raw Material Control on Regulatory Front Burner

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The feature story referenced here centers on the challenges and developments around raw material control for biological products. A main focus is the discussion that took place at a USP workshop on the raw material issues held in April 2021. The story’s three parts delve into: ● FDA views on where the regulatory concerns and expectations lie across the review and inspection continuum ● how the challenges expand in handling raw materials in the CGT context, and ● where biomanufacturers are in using and controlling polysorbates, in particular.

This article featured in IPQ's Monthly Update explores the pressing issues around raw material control in biotech processes and products – how the regulatory expectations and industry control practices are evolving as the knowledge base increases in depth and breadth.

A central focus is the rich discussion that took place at a USP workshop on “best practices and quality standards” for raw materials used in biomanufacturing, held virtually in April 2021. The third part of the story also brings in the significant light shed on the polysorbate issues at a CASSS CMC Strategy Forum on “the impact of excipients and HCPs on the formation of particles in biologics,” held in conjunction with the 2020 CASSS annual WCBP conference.

A review of the starting material issues facing peptide and oligonucleotide developers and manufacturers, in particular, was provided in Part IV of our recently released story focused heavily on the peptide/oligo workshop held by USP in March 2021?(see IPQ?August 9, 2021).

Also highly relevant to the discussions that took place at the April USP raw materials workshop is a multipart story released last year?(see IPQ?March 20, 2020)?exploring the industry/agency/pharmacopeia dialogue around the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.

Included in that story is a discussion of a proposal that was then under consideration at the agency for developing an independent novel excipient review process. FDA?had recently announced?the launch of a pilot program providing “a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations.” The program is intended to help foster novel excipient development and address the current approval challenges. During the two-year pilot phase, FDA will select two proposals to proceed through the program each year.?

The agency’s discussion of the reason for the review pathway in the pilot description very much complements the discussion of the raw material control issues in this article featured in a previous issue of our Monthly Update.

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IPQ provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms and universities around the world.

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