FDA’s BLA Review Sheds Light on Evolution of Biotherapeutic Product Analytical Methods and Their Regulation

Research by FDA’s Office of Biotechnology Products (OBP) into its database and experience with biological license application (BLA) reviews is revealing a lot about the evolving landscape of biotherapeutic product analytical methods and regulatory expectations.

The OBP review is providing a clearer picture of: ● what the current analytical toolbox looks like ● how methods are being used across the product lifecycle ● the relationship between the use of new analytical technologies and product approvals, and ● the challenges that present themselves in the effort to transition new methods from the development and characterization arena to their use in quality control (QC).

In discussing the findings at recent conferences, OBP’s review staff is offering substantive advice on what biotech companies need to be doing to make their analytical programs as meaningful as possible and what needs to be conveyed to the agency about their methods to facilitate the product approval process.

The 2018 CASSS WCBP Symposium on “The Interface of Regulatory and Analytical Sciences for Biotechnology Health Products” in Washington, D.C. in late January and the CMC Strategy Forum on “Next Generation Biotechnology Product Development, Manufacturing and Control Strategies” held in Gaithersburg, Maryland in July provided opportunities for OBP reviewing officials to share valuable insights on how analytical methods and the accompanying regulatory expectations for therapeutic proteins are evolving.

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