Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar.  Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration.

ICH Q6B, approved in 1999 by the three ICH regions, outlines specifications, test procedures, and acceptance criteria for biotech products. Q6B specifically calls for structural characterization and confirmation of the amino acid sequence and composition, terminal amino acid sequences, peptide map, sulfhydryl group and disulfide bridges, and the carbohydrate structure. With the more recent passage of the ICH quality guidelines, Q8, Q9, Q10 and the pending Q11, industry has even more information (as well as more expectation) on how to conduct a risk- and quality-based analysis of these products to ensure their safety.

A series of presentations on how to conduct biopharmaceutical characterization in detail was given yesterday in Valley Forge, Pennsylvania, by SGS Life Science Services and its recently acquired M-Scan Group, which focuses on mass spectrometry and gas chromatography for chemical analysis of both small and large molecule products.

Also discussed were biosimilars, which while making headway in Europe (14 have been approved since 2006), are still awaiting an implementation plan for approval in the US. Once that plan is in place—FDA continues to promise that it will be soon—bioequivalence, interchangeability, and comparability tests will become more commonplace. In the meantime, fully understanding and characterizing one’s product—down to the tiniest and most random chromatographic peak—remains a crucial part of the process and an expectation that is here to stay.