Biosimilar Characterization - Teriparatide

Regulatory approval of biosimilars depends on the quality and comprehensiveness of the data generated through the comparative analytical, in-vivo and clinical studies. Most crucial factor in establishing the bio-similarity between the biosimilar and the innovator’s product is the detailed analytical structural and functional characterization. Shantani’s aim is to support the regulatory requirements of biopharma developers, by providing comprehensive comparability analysis, based on the totality of the analytical evidences. We utilize well established workflows to generate high quality analytical data, as per the ICH-Q6B guidelines. In the article shared here (published in the March 2019 edition of Cutting Edge Spinco Biotech magazine), we are showcasing few examples of the primary and secondary structure characterization and comparability studies between the Biosimilar and Reference Teriparatide samples; which were performed at Shantani using well optimized Standard Operating Procedures (SOPs).