FDA May Ask for More Data on Higher Order Protein Structure in Biotech Applications

As methods and technologies designed to unravel the complexities and intricacies of protein folding,  structure and function become more reliable and available, FDA is looking at whether it is time to begin requiring more detailed information on higher order protein structure in biotech product applications.

The importance of understanding higher order protein structure and its relationship to product safety and efficacy was explored by CDER Office of Biotechnology Products (OBP) Biochemistry Laboratory Chief Emily Shacter at the FDA/CASSS CMC Strategy Forum in Barcelona, Spain in late March.

Shacter explained that the agency is not generally seeing higher order structure evaluations in submissions and is questioning whether and in what context more information should be supplied.

“Very little of what we know about the higher order structure of proteins is applied in biotechnology submissions to the agency,” Shacter pointed out.  “This is not because methods are not available – they are, and some of them are amenable to a QC environment.  But we still do not see them very much.”

In turn, FDA is considering whether it is “time to raise the bar” on expectations for this kind of data.  And if so, then “in what cases would we do that?’  When does it make sense to do this? When will the information be important and meaningful? And when would it not make sense?”

[Shacter’s review of the role of higher order structure analysis and the regulatory implications is provided for subscribers here.  The full story can be purchased for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org).  For subscription/license information, click here.]