CMC/MANUFACTURING definition
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Antibody and/or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, qualification of one or more Antibody production facilities and one or more radiolabeling facilities.
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Compound and / or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill / finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, and qualification of one or more Compound and Product production facilities.
CMC/MANUFACTURING means, as applicable for a particular Collaboration Product, CMC Step 2 or CMC Step 4. “CMC Manufacture” shall have a correlative meaning.
More Definitions of CMC/MANUFACTURING
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols.
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical Development and Commercialization necessary to achieve a scale of [*] per aggregate batch, defined as the sum of the batch size capacities of development facilities. This includes, without limitation, formulation, production, fill-finish, sourcing of plant, equipment, components, raw materials and packaging supplies, development of regulatory methods and controls, including assays, quality control and quality assurance methodology and stability protocols, and qualification and scale-up of one or more production facilities.
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Product for Preclinical Development, Clinical
CMC/MANUFACTURING means the development of one or more processes for the manufacture and packaging of the Antibody and/or the Product for Preclinical Development, Clinical Development and Commercialization, and shall include, without limitation, formulation, production, fill/finish, sourcing of components, raw materials and packaging supplies, development of