Certificate in Monoclonal Antibody Manufacturing & Supply
-- ViewingNowThe Certificate in Monoclonal Antibody Manufacturing & Supply is a comprehensive course designed to equip learners with critical skills in the production and distribution of monoclonal antibodies. This certification is essential in today's biotechnology industry, where monoclonal antibodies are at the forefront of therapeutic and diagnostic solutions.
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⢠Introduction to Monoclonal Antibodies: History, development, and applications
⢠Principles of Antibody-Antigen Interactions: Specificity, affinity, and avidity
⢠Cell Culture Techniques: Cell line development, seed train, and scale-up
⢠Upstream Processes: Media formulation, production, and purification of monoclonal antibodies
⢠Downstream Processes: Filtration, chromatography, and viral inactivation
⢠Formulation and Fill-Finish Operations: Excipients, stability, and aseptic processing
⢠Quality Control and Assurance: Analytical methods, release testing, and documentation
⢠Regulatory Compliance: FDA guidelines, ICH quality standards, and cGMP principles
⢠Supply Chain Management: Logistics, distribution, and inventory control
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