definiens: or means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, inspection, testing, shipping, storage, supply, handling, or freight of any pharmaceutical or biologic product ( or any components or process steps involving any product or any companion diagnostic ), placebo, or comparator agent, as the case may be, including cell line development, quality assurance and stability tes ting, characterization testing, manufacturing, quality control release testing of drug substance and drug product, quality assurance batch record review and release of product, quality control, process development, qualification, and validation, scale -up, pre - clinical, clinical, and commercial manufacture, analytic development and supply, initial manufacturing licenses, approvals and inspections, qualification and validation of Third Party contract manufacturers, stability and release testing, equipment val idation, testing and release, packaging development and final packaging and labeling, shipping configurations and shipping studies, and product characterization, and overseeing the conduct of any of the foregoing but excluding activities directed to Develo pment, Commercialization, or Medical Affairs . and will be construed accordingly