Comparability 2018-05-04T05:40:12+00:00

Comparability protocols for biologics

[6-8] are based on the realization that changes in a manufacturing process, equipment, or facilities could result in changes in a biological product that would affect the products safety and efficacy.  Comparability protocols are aimed at reducing the risk of such changes by outlining strategies for comparing the properties of pre- and post- change materials.

ICH Q5E [6] suggests that the assessment of comparability between the pre- and post- change product relies on the ability to show experimentally 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 considered the cornerstone of a comparability exercise.  SSCI offers support in comparability study from analytical evaluation (identity, purity/impurity, high order structure) to biological characterization (ligand binding and functional assay).