CMC Development definition
CMC Development means all research and development activities conducted in respect of the Manufacture of Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale-up, qualification and validation, quality assurance and quality control processes and techniques.
CMC Development means Development activities related to the CMC of drug substance and drug product intended to ensure the proper identification, quality, purity and strength of the drug, including test method development and stability testing, process development, drug substance development, delivery system development, technology transfer, process validation, process scale-up, formulation development, quality assurance and quality control development.
CMC Development means test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, technology transfer and other related activities directed to establishing Manufacturing for a Product.
Examples of CMC Development in a sentence
For clarity, Dynavax shall be responsible for conducting or having conducted all CMC Development for the Vaccine Candidate and related Product after the Effective Date, at Dynavax’s sole cost and expense, but excluding CMC Development of the Vaxart Platform generally or the Vaxart Platform for use or incorporation in compounds that are not Compounds or products that are not Products, for which Vaxart shall be solely responsible at Vaxart’s sole cost and expense.
More Definitions of CMC Development
CMC Development means the CMC-related Development activities related to the composition, manufacture, and specification of a Product intended to assure the proper identification, quality, purity and strength thereof, including: site transfer, test method development and stability testing, process development, process improvements (improving product robustness or manufacturing efficiencies), drug substance development, process validation, process scale-up, formulation development, delivery system development, QA and QC development.
CMC Development means chemistry, Manufacturing and controls development activities with respect to the Molecules and Products, including active pharmaceutical ingredient and formulation development, test method development, Manufacture/testing of active pharmaceutical ingredient and formulations (including placebos) for use in Clinical Studies, quality assurance, quality control development, development of the Manufacturing Process for the Products, scale-up, Manufacturing Process validation, including validation batches, Manufacturing Improvements, and qualification and validation of Third Party contract manufacturers.
CMC Development means the Development activities related to the composition, manufacture, and specification of the drug substance or biologic molecule and the drug product or biologic molecule (including combination products) intended to assure the proper identification, quality, purity and strength of the drug, including site transfer (as conducted pursuant to and in accordance with this Agreement), test method development and stability testing, process development, process improvements (i.e., improving product robustness or manufacturing efficiencies), drug substance or biologic molecule development, process validation, process scale- up, formulation development, delivery system development, quality assurance and quality control activities.
CMC Development means all research and development activities conducted in respect of the Manufacture of COVID Products, including chemistry, manufacturing and control (CMC), creation of master and working cell banks, test method development and stability testing, process development, manufacturing scale-up, qualification and validation, quality assurance and quality control processes and techniques.
CMC Development means (a) Development activities related to the composition, manufacture and specification of Compound API and Product intended to assure the proper identification, quality, purity and strength of the Product, including: test method development and stability testing, process development, Compound API process development, process validation, process scale-up, formulation development, packaging development, quality assurance and quality control development; and (b) preparation of CMC Regulatory Materials.
CMC Development means test method development and stability testing, process development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, technology transfer and other related activities directed to establishing Manufacturing of a drug or biological product.
CMC Development means all activities relating to the manufacturing of the Compound and Product for the supply of clinical and commercial quantities of Product, including test method development and stability testing, formulation, process development, manufacturing [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.