Goodwin Biotechnology will Design your Approach for Characterization and Comparability Studies of the Innovator Drug Product and your Biosimilar Drug Candidate
A Biosimilar needs to have quality attributes that are very similar to the innovator product. Therefore, it is critical to characterize the reference product very thoroughly so that the targets for identity and purity profiles are understood. Then, similarity can be established by conforming to the known quality standards and established reference standards. In the event that uncertainties are identified, they will have to be evaluated for potential clinical significance to ensure similarity and possibly interchangeability.
At Goodwin Biotechnology, we offer a wide array of analytical assays to demonstrate adequate comparability, in addition to full characterization and stability studies that are essential in testing of Biosimilars and in providing a side-by-side comparison to the Reference Innovator Drug Product. Key considerations that must be addressed include identity (primary, secondary, tertiary and quaternary structure), purity, potency, safety and immunogenicity.
Strategic approaches toward performing comparative characterization of a Biosimilar versus an innovator product involve two-fold approaches:
Analytical Assays that may be selected for side-by-side comparability testing with the innovator drug include:
For more information on our Biosimilars services please fill out the form below.
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