Biosimilars Testing Services
Biosimilar quality and safety testing including bioanalytical (immunogenicity) and biosimilar analysis to demonstrate comparability and similarity of the biosimilar product to a reference or originator biologic drug.
Biosimilars (also known as 'follow-on biologics' or 'follow-on biopharmaceuticals' in the USA), are complex protein structures that present a challenge to characterisation. Extensive comparability testing is required to demonstrate a comparable profile to the originator product as minor changes in bioprocessing can alter the product's character, safety and efficacy.
Various analytical assays for structural, physico-chemical and biological properties can be applied to demonstrate comparability between production batches of a potentially similar biopharmaceuticals side-by-side with the originator. Analytical strategies must provide comparative data assessing the primary and higher order structure. These include protein content, amino-acid sequence, post-translational modifications including disulphide bridges and glycosylation, and spectroscopic profiles. The potency, physiochemical integrity, stability, impurities, as well as Bioanalytical testing for preclinical and clinical studies (Immunogenicity and PK assays) must all be well understood.
Intertek's Biosimilar analysis and bioanalysis experience includes:
- Erythropoietin (Epoetin)
Biosimilars Analysis Services
- Biosimilar Comparability Studies
- Protein Analysis in line with ICH Q6B
- Stability Testing of Biologics and Biosimilars
- Biopharmaceutical Process and Product Related Impurities Analysis
- Biologics and Biosimilar Product Release Testing
Biosimilars Bioanalytical Services
Request more information to see how Intertek can help your organization with Biosimilars Testing Services.