Assessing the difference between biopharmaceutical products
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.
Comparability studies are tailored to your drug product
We perform comparability studies will be tailored to your specific drug substance and existing knowledge and data about your drug product. We transfer existing methods to your labs and/or conduct a de-novo method development. Click on a product type to explore our entire portfolio of specialized development and analytical services.
Quality & biosafety level of this service
We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:
Our know-how related to comparability studies
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.