definiens: means, with respect to a Product or component the reof ( e.g., ACTR T - cells or SGI Antibodies ), those manufacturing - related activities that support the Research, Development, seeking an d obtaining of Regulatory Approvals, and Commercializ ation of such Product, including manufacturing proc ess development and scale - up, validation, qualification and audit of clinical and commercial manufacturing facilities, bulk production and fill / finish work, r elated quality assurance technical support activiti es and CMC Activities, and including, in the case of a clinica l or commercial supply of such Product, the synthes is, manufacturing, processing, formulating, packaging, labeling, holding, quality control testing and rele ase of such Product . has a correlative meaning . For clarity, the term will include all processes from in a patient, includi ng withdrawing cells, transporting cells to and fro m the manufacturing facility(ies ) and reinfusing cells