Bioanalytics – Biomolecular
Bio-comparability studies are to ensure that a change in manufacturing process will not have an adverse impact on the quality, safety and efficacy of biological products. Changes in manufacturing processes to a biopharmaceutical product are often made during development and even after post-marketing to drive yield improvement, product quality or product stability. In addition, the development of biosimilar products has also grown rapidly over the past several years in-part due to several approved biologics have reached patent expiry. In both situations, bio-comparability of a test product to the reference product must be demonstrated through physiochemical and structural characterization, and similarity studies that compare the safety and efficacy profiles of both products. At minimum, pharmacokinetic (PK) similarity studies between test and reference products are often required.
When those clinical PK studies fails to meet the predefined criteria, investigations are initiated. Bioanalytical (BA) scientists need to come up with a detailed investigation when bioanalytical error(s) is suspected. In this session, scientists will present different case studies, regulatory trending and share first-hand/expert experiences in conducting investigation of failed bio-comparability/biosimilar studies and approach in resolving a failed bio-comparability study issue.