This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for a clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical, and quality elements, implementation, and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as an illustration and proper time will be allowed for discussion designs and outcomes.