Developability Assessment

What are these studies and why are they required?_copy20240715

Comparability studies are important to ensure that process changes made during the process development and/or manufacturing will not have an adverse impact on the quality, safety and efficacy of biopharmaceuticals. According to the ICH Q5E guidelines, comparability studies should provide analytical confirmation that the drug substance or drug product has similar quality attributes, pre- and post-process changes, which could be necessary during drug development and/or after approval. To meet this goal, the product should be characterized at the process step most appropriate to detect a change in the quality attributes. The list of analytical tests for the comparability studies should be carefully selected to maximize the potential for detecting relevant differences in the quality attributes of the product that could result from the proposed process change.

What encompasses Comparability Studies?_copy20240715

Primary amino acid sequence analysis by peptide map
Intact mass analysis
Reduced mass analysis
N- and C-terminal sequence analysis
Disulfide bonds and sulfhydryl groups mapping
Anlysis of other post-translational modifications including the N- and O-glycosylation
Higher order structure analysis
Biological characterization and potency assay
Purity and impurities profiling

What we provide?_copy20240715

Our teams at Crystal Pharmatech Biologics Analytical Services design and perform comparability studies according to ICH Q5E and ICH Q6B guidelines. Our team carry out an array of analytical methods guidance aspects ranging from biomolecular structural features such as primary, secondary, and higher order structure to assessment of physicochemical properties. We also provide biological characterization and potency assay services.

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