Chemical and Analytical Strategies for Biosimilars


Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of Biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of Biologics and Biosimilars products. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.



While small changes in these parameters can impact the various chemical permutations for a given biotherapeutic, innovators can, under certain circumstances, change the host cell, fermentation process, purification process, and even manufacturing site, but the product can be validated without undertaking a complete new product development review.



 


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