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4 BioPharm International eBook July 2021 www.biopharminternational.com Complex Biomolecules Require Analytical Evolution The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers. T he structure and activity of complex biother- apeutic molecules require sensitive analytical technologies that can characterize these com- plicated protein structures and observe their pharmacok inetic activit y, elements funda- mental to biotherapeutic drug development and production. Relevant technologies are needed to make detailed analyti- cal assessments of structure and function, and further inno- vation is needed to address the continued challenge faced by the industry. THE PROBLEM WITH COMPLEX BIOLOGICAL MOLECULES The structure of biological molecules poses interesting chal- lenges to analytical assessment. Elucidating the purity or structure of a complex biological product often requires methods designed uniquely to the analyte, multiple analyti- cal assays that leverage cross-modal technologies, and orthog- onal analytics to differentiate the analyte from a biosimilar molecule, says William Bakewell, research fellow at PPD Laboratories' GMP Lab. A fundamental challenge, says Shawn Fitzgibbons, man- ager, Catalent Biologics, is the large size of biologics mate- rials, and, in turn, the micro-heterogeneity observed with respect to each attribute measured. "Every molecule will have unique characteristics, for example, although charac- terization of post-translational modif ications is routinely addressed, there may be a specific challenge if the molecule has a high level of modifiable residues at, or near, important binding regions of the molecule, or if the molecule is par- ticularly prone to these modifications because of its given formulation," he says. FELIZA MIRASOL Biopharmaceutical Analysis Analytical Evolution Kateryna_Kon - Stock.adobe.com