Showing comparability of recombinant monoclonal antibodies (mAbs) is important in two different fields of development. On one hand, for process changes in the life-cycle of mAbs, the purpose of comparability is to demonstrate that pre- and post-change drug products are comparable in terms of quality, safety, and efficacy. On the other hand, for the development of biosimilars, it is required to compare the biosimilar to the innovator product in terms of the structures and functions.
With years of experience in antibody development, characterization, and manufacturing, Creative Biolabs provides analytical comparability studies of mAb therapeutics for both evaluating the key quality attributes of your mAb candidates to help you ensure that process changes do no impact product quality, efficacy, or safety, and demonstrating similarity of your candidate to a reference or originator product.
Designed to be highly similar to originator biologic products, biosimilars represent an opportunity to increase access and reduce costs for patients and healthcare systems. Regulatory submissions for biosimilars are typically assessed on a ‘weight-of-evidence’ based approach, in which the biosimilar developer provides data demonstrating comparability with the innovator product. This usually depends on the use of state-of-the-art analytical methods to look at the physiochemical, structural, and biological potency attributes.
Fig.1 Biosimilarity assessment of biosimilar therapeutic mAbs. (Ishii-Watabe, 2018)
With many years of experience, we can propose an appropriate analytical strategy for comparability assessment of biosimilars, based on the criteria outlined in ICH Q6B. Programs are designed to compare structural and physiochemical characteristics, impurity profiles, biological activity (cell-based assays and binding assays), and stability profiles, all of which are pertinent product attributes that need to be determined.
Process changes that affect their safety and efficacy are inevitable in the life cycle of mAb therapeutics. The goal of this internal comparability study is to demonstrate that the pre-change and post-change products are comparable. At Creative Biolabs, we develop comparability protocols to help ensure that process changes do not impact the critical attributes of products by outlining strategies for comparing the properties of pre- and post-change materials. Per ICH Q5E, we assess comparability between the pre- and post-change product by showing experimentally that the samples are highly similar in terms of physiochemical and biological characteristics, degradation profile, pharmacokinetic, and immunogenicity at different stages of a product’s life cycle.
Physiochemical characterizations, biological assays and stability degradation profiles of the drug product are the cornerstones of a comparability study. We offer comparability study support from the analytical evaluation (e.g., high-order structure, chemical modifications, glycosylation) to biological characterization (e.g., ligand binding and function assays).
Creative Biolabs is equipped with a broad range of analytical techniques and assays that allow us to evaluate the product comparability from all aspects. Besides, we offer tailored programs and protocols to meet different/special requirements and provide expert technical and scientific support to our clients throughout the development process.
Please contact us if you are interested in our comparability study services.
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