Comparability Studies
Our experts design comparability studies with tailored analytical programs, created in accordance with the ICH Q5E guideline on comparability of biotechnological/biological products, to ensure manufacturing process changes do not impact your drug product’s critical quality attributes.
Successful Comparability Studies Require Extensive Analytical Expertise
Due to the complexity and natural variability of biological drug products, advanced analytical methods are often required to detect relevant differences for successful comparability studies. Coriolis Pharma offers a wealth of experience and expertise combined with the utilization of advanced analytical techniques for physicochemical, functional, conformational and higher-order structure analyses, as well as the comparability of stability profiles.
Comparability Studies for Your Biosimilar Program
Advanced comparability studies are often required for biosimilar development programs as it is crucial to assess a biosimilar candidate’s quality attributes in relation to its originator reference product. These studies should be integrated early in the development process, including preformulation and formulation stages, and should encompass a comprehensive set of analytical methods as outlined in the ICH Q6B guideline.
Comparability Studies for Your Drug Product
We design comparability studies for many biopharmaceutical drug products (innovator and biosimilar products), including highly concentrated protein formulations and active pharmaceutical ingredients like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Coriolis designs phase-appropriate comparability studies to support manufacturing process changes and biosimilar programs. We conduct these studies throughout the phases of development, including:
Comparability Studies Resources
Live Webinars
Developability Assessment and Early Formulation Studies for Biologics
February 27, 2025
Publications
December 2, 2024
Articles
Partnering with Scientific Excellence to Derisk and Accelerate Drug Development
July 15, 2024
