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FDA is Advising Biotech Product Applicants to More Clearly Justify Their Excipient Usage

Mar 28th, 2016

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FDA’s Office of Pharmaceutical Quality (OPQ) is asking biotech product sponsors to fully explain the process used to select excipients and to provide a risk assessment on potential interactions between the excipients and their proteins.

The agency wants to be sure that the biotech manufacturers understand the full ramifications of the way they are using excipients and how the product/excipient interactions differ from their use in the small molecule context.

At a mid-November workshop on “Excipient Quality, Compendial Testing, and Regulatory Impact,” sponsored by USP and held at its Rockville, Maryland headquarters, OPQ Office of Biotech Products (OBP) Acting Applied Biochemistry Lab Chief Ashutosh Rao provided OBP’s perspective on the selection of excipients for biotech products and highlighted some of the problems his office has seen.

[The story continues for subscribers beginning on page 2. Included is a discussion at the USP conference by OPQ Office of Policy for Pharmaceutical Quality (OPPQ) Biology Team Leader Laurie Graham of excipient risk assessments and the challenges CMC reviewers face regarding excipients in reviewing biotech applications. Nonsubscribers can get information on IPQ subscriptions/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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