Biosimilars Testing Services
Biosimilar quality and safety testing including Bioanalytical (Immunogenicity and PK) and biosimilar analysis to demonstrate comparability and similarity of the biosimilar product to a reference or innovator biologic drug.
Biosimilars (also known as 'follow-on biologics' or 'follow-on biopharmaceuticals' in the USA), like the reference biologic product, are complex protein structures that present a challenge to characterization. Extensive comparability testing is required to demonstrate a comparable profile to the reference 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 alongside comparison with a reference drug (similarity). These include protein content, primary, secondary and higher orders structure, potency, physiochemical integrity, stability, impurities and additives, as well as Bioanalytical testing for preclinical and clinical studies (Immunogenicity and PK assays).
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.