Changes in a manufacturing process, equipment or facilities can result in changes in a biologic that affect its safety and efficacy. We develop comparability protocols to reduce the risk of such changes 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, pharmacokinetics and immunogenicity.
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 analytical evaluation (identity, purity/impurity, high order structure) to biological characterization (ligand binding and functional assay).