Detailed comparability studies covering the physicochemical, structure and biologic potency characterization of a range of biosimilars and biopharmaceuticals
Comparability studies are of major importance in the development of biosimilars and biopharmaceuticals. These studies are key to the development of biosimilars, which is a process that is chiefly concerned with the comparability of the biosimilar to the originator drug product – this relies on detailed analytics. For innovative products, these studies demonstrate comparability which may be required to qualify sources of clinical trial materials following process development, optimization, and scale-up.
Based on many years of experience, Intertek offers a strategic approach to biosimilar analytical programs that provide highly relevant early stage characterisation and later stage comparative data. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the criteria outlined in ICH Q6B. Programs encompass many different analytical techniques and provide information ranging from evaluation of physiochemical properties and structural features including primary, secondary and higher order structure and assessment of post-translational modifications (PTM) to determination of biological potency and assessment of purity / impurity profiles.
We are highly experienced in comparability studies conducted to Good Laboratory Practice (GLP) or Good Manufacturing Practice (cGMP) standards for biosimilars, monoclonal antibodies and recombinant proteins.
Biologics comparability services include:
Protein physicochemical properties
Protein structure analysis
Liquid chromatographic patterns
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