KBI Biopharma, Inc. – FDA EIR, Mar 6, 2020

An FDA pre-approval inspection of KBI Biopharma, Inc. in Boulder, CO, occurred from March 2 to March 6, 2020. The inspection assessed the firm's adherence to Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (ICH Q7) and requirements under Compliance Program Guidance Manual 7346.832M for pre-license therapeutic biological products. The primary focus was a Comparability Protocol submitted to the FDA for a proposed change in drug substance storage temperature.

The main observation detailed in an FDA Form 483 highlighted that a critical characterization study, intended to support the storage temperature change, did not meet system suitability criteria during analytical testing for drug substance concentration, thereby invalidating the final quality control results. Despite KBI management's initial assertion that GMPs were not strictly required for this characterization study, the FDA emphasized the necessity of robust, reliable data for Biologics License Application supplements and adherence to validated analytical methods.

Additional discussions with management addressed concerns regarding microbiological plating techniques that could lead to underreporting of bioburden and potential gaps in data integrity controls for chromatographic system injections. KBI Biopharma's Executive Vice President was reminded of cGMP responsibilities and potential regulatory actions for non-compliance. A formal response addressing the Form 483 observation is required within 15 business days. The inspection also noted voluntary corrections to several issues cited in a previous 2018 inspection.