Samantha Little
Covance Laboratories Ltd, UK
Title: Development of a biosimilar CMC strategy for the identification of critical quality attributes
Biography
Biography: Samantha Little
Abstract
To support a claim of Biosimilarity, the EMA and FDA are interested in the ‘totality of evidence’ where the molecule and its physicochemical and biological attributes are assessed from the perspective of clinical relevance. The assays used in these assessments need to have the ability to identify where changes in the molecule are key to clinical efficacy. There is no type of assessment which alone is capable of verifying biosimilarity. As such an orthogonal approach combining physicochemical and functional analysis is required. Results from this approach should be reflective of a molecules critical quality attributes and should hopefully minimize the extent of any clinical studies required for verification of biosimilarity, safety and efficacy. A large challenge for Biosimilars is understanding the structural function association as it relates to the activity of the antibody. Characterisation of IgG1 glycosylation has been shown to be of utmost importance, as it can impact the mode of action. We present a case study which exemplifies how identification of critical quality attributes linked to the known mode of action could have mitigated risk to a Biosimilar development program at the CMC characterisation stage. A CMC strategy has been employed to link quantitification of glycosylation with the mode of action.
