Manufacturing Process Development definition

Manufacturing Process Development means the process development, process qualification and validation and scale-up of the process to manufacture the Compound, a Derivative or a Product and analytic development and product characterization with respect thereto.
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Manufacturing Process Development means the development of initial manufacturing processes and analytical methods (e.g., in-process and final quality control and quality assurance protocols and methods) to support the manufacture (including release) of Product using the Manufacturing Strain. For clarity, Manufacturing Process Development includes the manufacturing experience of Pfenex with respect to the Product up to and including the Signature Date.
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Examples of Manufacturing Process Development in a sentence

  • Each Party shall have the right to audit the records of the other Party with respect to any Development Costs and Manufacturing Process Development Costs included in such reports, in accordance with Section 9.10.

  • Each Party shall submit any additional information reasonably requested by the other Party related to the Development Costs and Manufacturing Process Development Costs included in its report within *** of its receipt of such request.

  • As soon as practicable after the Effective Date, but in any event within fifteen (15) days of the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to oversee the Development, Process Development, Manufacturing, Process Development and Commercialization activities of the Parties with respect to Product in the Territory during the Term as further detailed in this Article 3 (GOVERNANCE).

  • Biogen will not enter into any new agreement or other obligation with any Third Party, or amend an existing agreement with a Third Party, in each case that restricts, limits, diminishes or encumbers the rights granted to Ionis under the Manufacturing Process Development Terms.

  • The JSC shall have review and coordination responsibilities for Development, Manufacturing, Process Development and Commercialization activities and in connection therewith shall review and provide advice regarding the overall progress thereof.

  • Pricing for Product and Manufacturing Process Development services will be provided to Customer in written proposals provided to Customer by BVL based on the services requested by Customer.

  • Within *** following the end of each Calendar Quarter beginning with the License Grant Date, each Party shall prepare and deliver to the other Party on a Licensed Program by Licensed Program basis a quarterly report detailing its Development Costs and Manufacturing Process Development Costs incurred during such period, with each Party reporting on all Development Costs incurred with respect to Development Collaboration Proposals.

  • Pfenex shall perform its responsibilities as set forth in the Development Plan, including (i) completion, at its expense, of the Pharmacokinetic Study, and (ii) using Commercially Reasonable Efforts to perform the Manufacturing Process Development work as described in the Development Plan.

  • Pfenex shall, upon the request of Hospira, provide Hospira with all records, documents, data and other information related to the development with respect to Product, including any Manufacturing Process Development work or Pre-Clinical Study conducted by or on behalf of Pfenex with respect to Product either before or after the date hereof, in each case as is reasonably requested by Hospira to conduct its obligations or exercise its rights hereunder.

  • Regulatory Clinical Quality Assurance Quality Control Analytical Methods Validation Manufacturing Process Development Tech Services Manufacturing Equipment – Engineering and Validation Process Validation Each Party may, by providing written notice to the other Party, designate another qualified person to replace the above personnel.

Related to Manufacturing Process Development

  • Manufacturing Process means any process for—

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.