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

  • 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).

  • 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.

  • Manufacturing Process Development (3.2.P.2.3) You should describe the selection and optimization of the DP manufacturing process (described in the “Description of Manufacturing Process and Process Controls (3.2.P.3.3)” section of the CTD) if development studies have been performed.

  • 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.

  • Manufacturing Process Development (3.2.S.2.6)You should provide a description and discussion of the developmental history of the manufacturing process as described in the “Description of Manufacturing Process and Process Controls (3.2.S.2.2)” section of the CTD.For early stage INDs, there may be differences between the manufacturing and testing of the toxicology lots and the material you plan to use in the clinical studies.

  • 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.

  • Within *** following the end of each Calendar Quarter beginning with the License Grant Date, each Party shall prepare and deliver to the other Party 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.

  • Distributions in respect of any subsequent Distribution Period will be payable on each Distribution Payment Date in arrear at the Floating Distribution Rate calculated on the amount of the Liquidation Preference.

  • The analytical procedures and corresponding validation should be cross-referenced (e.g., 3.2.S.2.4, 3.2.S.4.3) or provided as part of justifying the selection of critical process controls and acceptance criteria.For manufacturing steps intended to remove or inactivate viral contaminants, the information from evaluation studies should be provided in 3.2.A.2.3.2.S.2.6 Manufacturing Process Development The developmental history of the manufacturing process should be provided.

  • This new process was followed for model 3 development in the year 2016.We changed the name of the process from “New Product Productionization” (NPP) to "New Product Manufacturing Process Development" (NPMPD) to make it more meaningful i.e. development of manufacturing process for new product, so that it suits the actual activities performed during the entire cycle.○1 New product requestThe marketing team requests for a new product based on the competitor analysis, customer requirements and change of law.

Related to Manufacturing Process Development

  • Manufacturing Process means any process for—

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Development Works means the external development works and internal development works on immovable property;

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Distillery manufacturing license means a license issued in accordance with

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.