Like all other pharmaceutical products, biopharmaceutical APIs and finished products undergo rigorous quality control in order to confirm conformance to pre-determined specifications. Products must be tested for identity, impurities, quantity, e.g., protein content and stability to ensure safety and efficacy of the biopharmaceutical products. Thorough quality control is also required by all GMP regulations and is frequently subject to regulatory inspections. Because of higher complexity, the analysis of biotechnology derived products involves more sophisticated analytical procedures.
The workshop will give a comprehensive overview of different analytical techniques used in biopharmaceutical quality control laboratories; workflow for product characterization profile; specifications and acceptance criteria.
In addition, product validation including reliable solution for identifying product degradation and monitoring them throughout production and also comprehensive portfolio of solutions for determining impurities such as host cell, metals and residual solvents would also be covered. Programme shall be conducted by trainers and faculty from Agilent Technologies, KIIT-Technology Business Incubator and other leading organizations.