Biosimilar quality and safety testing including analytical and bioanalytical comparability of the biosimilar product to a reference or originator drug
Biosimilars (also known as ‘follow on biologics’ in the USA) present many unique analytical and bioanalytical challenges driven by the complexity of their structure and biologic function. The development of a biosimilar is chiefly concerned with establishing the comparability (European Union) / or similarity (USA) of the biosimilar to the originator and confirmation of similarity – this relies on detailed analytics looking at physiochemical, structural and biological potency attributes. This process is followed by appropriate preclinical and clinical trials and associated pharmacokinetics, immunogenicity, pharmacodynamics bioanalysis supporting comparative safety and efficacy studies.
Based on many years of experience, we offer a strategic approach to biosimilar analytical comparability 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 and cell-based assays to determination of biological potency. We also deploy a range of mass spectrometry and chromatographic techniques to assess process impurities and product related impurity profiles.
Intertek’s GLP immunochemistry capabilities are world renowned for developing and validating assays for pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamic (PD), immunogenicity, efficacy and safety biomarker studies with diverse immunochemistry technologies (e.g. ligand binding assays), radioimmunochemistry (RIA) and functional (e.g., enzymatic and cell-based assays) assay platforms.
Our extensive expertise in the development and validation of immunochemistry and functional assays provide industry-leading bioanalytical support for PK, TK, efficacy and safety studies throughout pre-clinical and clinical development of biological therapeutics in full regulatory compliance (FDA, EMA and OECD GLP regulatory standards) as well as non-GLP exploratory studies tailored to the sponsors’ needs for biosimilar drug development.
The diversity and relevance of our services combined with the experience of our biopharmaceutical scientists provide expert support to our clients throughout the development and manufacturing process. Our wealth of experience and depth of industry knowledge enables clients to navigate the challenges of biosimilar development, confirmation of biosimilarity, comparative safety and efficacy studies and also market release. With facilities located in India, Europe (UK, France, and Switzerland) and the USA, Intertek provides the solutions to support your needs and to accelerate your products to market.
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