Services For Biosimilars

Biosimilars are complex protein structures that require characterization to demonstrate comparability to the original biologic. Comparability testing often involves a range of analytical and bioanalytical assays that assess a drug product's physiochemical and biological properties to demonstrate acceptable comparability between the biosimilar and originator. Biosimilar testing also includes assessments of product efficacy and stability in support of clinical development. At BioReliance, we offer a comprehensive array of assays and services to support your biosimilar development program. From initial product characterization to full comparability studies, we can meet your development needs every step of the way. See our links below to learn more about our service areas:

• Analytical Services
• Bulk Lot Release Testing
• Final Product Lot Release Testing
• Immunoassay and Cell Based Assay Services