Biotherapeutics and Bioanalytical Techniques

Analytical Biotherapeutics

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Analytical biotherapeutics include identity by microbiological characterization of the strain, purity (monosepsis), strength by determination of viability, development of cell based potency assays. This also includes advanced characterization technologies for a range of complex therapeutic proteins to provide complete understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. Analytical Biotherapeutics mainly focuses on assay and validation methods, hot spots identification, post-translational modifications, impurities, critical quality attributes formulation and stability.