Slight changes in formulation conditions or the production process potentially affect the safety and efficacy of the drug product. It is, therefore, necessary to perform detailed comparability studies to assure that product quality and degradation profile have not quantitatively worsened or even qualitatively altered. If analytical characterization and non-clinical comparability studies are not sufficient for this claim, the ICH Guideline Q5E demands additional clinical comparability studies.

Comparability assessment requires sensitive and suitable analytical methods

“The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical,” says the ICH Q5E guideline, ”But that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product.”

Due to the complexity and natural variability of biological drug products, analytical methods aiming to detect relevant differences are essential for such studies. Setting up comparability studies requires a lot of experience and scientific know-how. Coriolis offers such wealth of experience and know-how combined with a large variety of analytical techniques for the physico-chemical, functional, confirmational and higher order structure analysis, as well as the comparability of stability profiles. 

Comparability of biosimilar and originator

During the development of biosimilars, comparability studies are vital to assess  a biosimilar candidate quality attributes with respect to its originator reference product. Such studies should be included already at early development stages during preformulation and formulation development and include a comprehensive set of analytical methods, as outlined in ICH guideline Q6B.