definiens: or means, as appl icable, all activities and operations associated with the production, manufacture, supply, receipt, processing, filling, finishing, inspecti ons, testing, packaging, labeling, shipping, warehousing, storage and handling of a Licensed Product or [COMPANY] Antib ody as applicable, including : cell line development ; proce ss and formulation development ; process validation ; stability and release testing ; manufacturing scale - up ; pre - cl inical, clinical and commercial manufacture and sup ply ; qualification and validation of Third Party contrac t manufacturers, scale up, process and equipment va lidation, and initial manufacturing licenses, approvals and i nspections ; analytical development and product characterization ; quality assurance and quality con trol development ; testing and release ; packaging de velopment and final packaging and labeling ; shipping configur ations and shipping studies ; and overseeing the con duct of any of the foregoing . When used as a verb, means to engage in Manufacturing