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Industry Weighs FDA Draft Guidance on CMC Changes for Certain Biologics

Posted 23 March 2018 | By Zachary Brennan 

Industry Weighs FDA Draft Guidance on CMC Changes for Certain Biologics

Industry groups BIO and PhRMA, as well as companies, including Sanofi, BD and GlaxoSmithKline, offered their praise and sought additional clarity on draft guidance from the US Food and Drug Administration (FDA) on changes to chemistry, manufacturing, and controls (CMC) information for certain biologics.

Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general and administrative information on reporting and evaluating CMC changes and recommendations for reporting categories. 

According to comments released Friday, both BIO and PhRMA said they supported FDA’s push to update the outdated 2007 version of the guidance.

BIO, however, noted that cellular, gene, and cell-based gene therapy products are included in the scope of the drug but excluded as exceptions in certain examples in an appendix.

“To promote longevity of this Guidance, when finalized, as more of these products are approved, we recommend a risk-based approach be adopted based on the level of evidence needed for the categorization of post-approval changes for these products,” BIO said.

BIO also sought clarity from FDA on several different terms used in the draft, including “cellular and cell-based gene therapy products,” ““cellular therapy and cell-based gene therapy products,” “gene therapy” products and “cellular and gene therapy products.”

The group said it suggests FDA “clearly define and distinguish these product types using consistent terminology with examples where possible and appropriate.”

BIO and GlaxoSmithKline also called on FDA to align the guidance with the final ICH Q12 guideline, once it’s complete, as well as other ICH guidelines.

PhRMA, meanwhile, expressed concerns that FDA is duplicating efforts for manufacturers and the agency by requesting information typically reviewed during a GMP inspection of a pharmaceutical quality system.

“In addition, PhRMA encourages FDA to incorporate ‘Guidance for Industry – Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (July 1997)’ and ‘Draft Guidance for Industry: Chemistry, Manufacturing, and Controls Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (2017)’ into this draft guidance,” the industry group said.

Sanofi questioned the draft’s inclusion of a "reference list of standard operating procedures (SOPs)" in any supplement.

“Sanofi does not believe that a reference list of SOPs should be required to assess the impact of the change on product quality. SOPs are reviewed as part of GMP inspections,” the company’s comment said.

BD, meanwhile, took issue with a provision in the draft that said, “it is incumbent upon the applicant to ensure that contract manufacturing and testing sites have a satisfactory CGMP status for the type of operation involved.” BD noted that for some specific operations, such as manufacturing of packaging components, contract manufacturing sites are not subject to FDA inspections so the evidence for a complaint CGMP status “cannot practically be given by the contract manufacturer nor FDA to the applicant.”


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