Engineering Run definition

Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps.
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Engineering Run means a fermentation run, at the same scale as the intended GMP batch, conducted for the purpose of testing a manufacturing process, identifying and resolving any potential issues with equipment or cGMP documentation prior to clinical GMP manufacturing, and supplying material for non-clinical use and/or stability studies. An Engineering Run is not for the purpose of manufacturing Product in conformance with cGMP.
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Engineering Run means each of the first [****(*)] Batches of GTC Product purified and tested by CBSMA pursuant to the terms of this Service Agreement including any Exhibits hereto. The Engineering Runs are not intended for inclusion in the Consistency Series, but after review by GTC of the Batch records and the QC release data, GTC, in its sole discretion, may deem such Batches suitable for use in pre-clinical and clinical applications.
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Examples of Engineering Run in a sentence

  • The Detector Engineering Group leaders also chair the daily (or similar cadence) Engineering Run Management meetings and closely coordinate with the LSC Operations Division during the run up to an observing run.•The Detection Coordinators work for the best science outcome and lead Observational Runs at the observatories.

  • Eachengineering run will consist of the four basic functions: archiving h[t] data, streaming h[t] data, archiving events, and streaming events.Thus each Engineering Run will pass simulated data through the detection pipelines, testing the data grid and issuing simulated events.

  • BELLEElectron and positron beam energies were increased by 2.7% (same Lorentz boost βγ = 0.425) to move from Y(4S) to Y(5S).-Y(5S) Engineering Run at the KEKB e+e- collider BelleNo modifications are required for Belle detector, trigger system or software to move from Y(4S) to Y(5S).3.5 GeV e+8 GeV e3 days of engineering run at Y(5S) : June 21 – June 23 , 2005.Energy scan (30pb-1 at 5 points) : Y(5S) peak position ECM = 10869 MeV was chosen.

  • Celebration of Science and Engineering Run each year at Glasgow Science Centre, this is a gathering of over 600 school pupils from across Scotland.

  • Engineering Run • Pfenex shall perform [*] to ensure reproducibility of previously drafted procedures.

  • A Run may be (a) an Engineering Run, or (b) a GMP Run.Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

  • However, this isolation is not perfect since both the PA and PM use the same low voltage supplies and a large spike in the HV system can overpower the isolation.Here are my recollections of the problems we have encountered in our attempts to put the PCS in SNO.The Engineering Run 30 Oct 20001.

  • In addition, there will be made available to the LIGO/MIT LDAS system approximately 1200 seconds of frame data beginning at GPS starttime 680938500 from both the LIGO Hanford and LIGO Livingston Observatories during the E5 Engineering Run.

  • For a Run, Evelo will pay to Biose amounts as follows: (i) an Engineering Run fee will be [***]; and (ii) a GMP Run fee will be [***]; provided, however, if Evelo elects to forego an Engineering Run for a given Strain before having Biose perform a GMP Run with such Strain, Evelo will pay to Biose [***] for such GMP Run (i.e., an additional [***] more than the normal [***] GMP Run fee).

  • The Manufacturing Price, Campaign Report Fee, Engineering Run Price and Annual Program Fee specified in Attachment 1 shall increase first on [***] and then on [***] of the consecutive years in an amount [***], if any, [***].


More Definitions of Engineering Run

Engineering Run means a non-cGMP Manufacturing run utilizing Master Production Records and intended to execute the series of unit operations in the specified order to evaluate whether or not the Manufacturing Process meets draft Product Specifications. For Engineering Runs raw materials and equipment will be used as for intended later cGMP manufacturing. Raw Materials for non-cGMP purpose do not require incoming goods controls, but QA release based on supplier certificates. Suppliers do not need to be audited at this stage. The Engineering runs are performed in the same cGMP clean rooms facilities and by the same trained personnel as for the intended later cGMP manufacturing. Engineering runs will not include deviations or OOS reporting in IDT’s Quality System. Engineering runs will include review by Production Record review team, QC record review team and QA, but no QP release. Product from Engineering Runs shall be considered as Development Product pursuant to Section 2.10.
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Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps. “Fujifilm Confidential Information” shall have the meaning set forth in Section 8(b).
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Engineering Run means: the process performed by SYNCO concerning the reintroduction of the manufacturing process of PTH and TEDUGLUTIDE in SYNCO's Facility, which product will be tested to confirm the Reintroduction Objectives can be met.
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Engineering Run means any non-GMP batch run with or without [*].
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Related to Engineering Run

  • engineering services means infrastructure for –

  • Engineering means the application of scientific knowledge for the design, control, or use of building structures, equipment, or apparatus.

  • external engineering service means an engineering service situated outside the boundaries of a land area and that is necessary to serve the use and development of the land area;

  • Engineering control means the use of substitution, isolation, ventilation, and equipment modification to reduce exposure to SARS-CoV-2 virus and COVID-19 disease related workplace hazards and job tasks.

  • Engineering Report means the Initial Engineering Report and each engineering report delivered pursuant to Section 6.2.

  • Initial Engineering Report means the engineering report concerning Oil and Gas Properties of Loan Parties dated as of June 30, 2016, prepared internally by the Borrower.

  • Geotechnical engineer means a professional engineer registered with the Association of Professional Engineers, Geologists, and Geophysicists of the Northwest Territories and whose principal field of specialization is the design and construction of earthworks in a permafrost environment;

  • Systems Engineering means preparing specifications, identifying and resolving interface problems, developing test requirements, evaluating test data, and supervising design.

  • Engineering Reports has the meaning assigned such term in Section 2.07(c)(i).

  • Architect/Engineer (A/E means a person registered as an architect pursuant to Tex. Occ. Code Ann., Ch. 1051, as a landscape architect pursuant to Tex. Occ. Code Ann., Ch. 1052, a person licensed as a professional engineer pursuant Tex. Occ. Code Ann., Ch. 1001, and/or a firm employed by Owner or Design-Build Contractor to provide professional architectural or engineering services and to exercise overall responsibility for the design of a Project or a significant portion thereof, and to perform the contract administration responsibilities set forth in the Contract.

  • Independent Engineering Report means a report, in form and substance satisfactory to the Administrative Agent and each of the Lenders, prepared by an Independent Engineer, addressed to the Administrative Agent and the Lenders with respect to the Oil and Gas Properties owned by the Borrower or its Subsidiaries (or to be acquired by the Borrower or any of its Subsidiaries, as applicable) which are or are to be included in the Borrowing Base, which report shall (a) specify the location, quantity, and type of the estimated Proven Reserves attributable to such Oil and Gas Properties, (b) contain a projection of the rate of production of such Oil and Gas Properties, (c) contain an estimate of the net operating revenues to be derived from the production and sale of Hydrocarbons from such Proven Reserves based on product price and cost escalation assumptions specified by the Administrative Agent and the Lenders, and (d) contain such other information as is customarily obtained from and provided in such reports or is otherwise reasonably requested by the Administrative Agent or any Lender.

  • Project Engineer means the surveyor or engineer employed by or private

  • Good Engineering Practice means, Works carried out in accordance with the following standards/ specifications,

  • Architect/Engineer or “A/E” means the Person identified in the Agreement responsible for providing professional design services and construction contract administration for the Project. The A/E shall be (1) a registered architect holding a license and certificate of authorization issued by the Ohio Architects Board pursuant to ORC Chapter 4703, (2) a landscape architect holding a license and certificate of authorization issued by the Ohio Landscape Architects Board pursuant to ORC Chapter 4703, or (3) a professional engineer or professional surveyor holding a license and certificate of authorization issued by the Ohio Engineers and Surveyors Board pursuant to ORC Chapter 4733. As used in the Agreement, the term A/E may include a criteria architect or engineer for a Design-Build project.

  • Structural Engineer means the Engineer appointed or to be appointed from time to time by Promoter for the preparation of the structural design and drawings of the buildings .

  • Bulk gasoline plant means a gasoline storage and distribution facility with an average daily throughput of 20,000 gallons (76,000 liters) of gasoline or less on a 30-day rolling average.

  • Value Engineering means the detailed analysis of systems, equipment, materials, services, facilities, and supplies required by the Contract Documents for the purpose of achieving the desired and essential functions of the Owner’s program at the lowest cost consistent with required and necessary performance, longevity, reliability, quality and safety.

  • Cannabis plant means any plant of the genus Cannabis;

  • Biodiesel means a fuel composed of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, and, in accordance with standards specified by the American society for testing and materials, designated B100, and meeting the requirements of D-6751, as approved by the department of agriculture.

  • Architect's Contract means Lessee's contract with the Project Architect.

  • Construction Plant means appliances, machinery with necessary supply to up keep and maintenance of the works or temporary works but dose not include materials or other things intended to form part of the permanent work.

  • Project Architect means the professional architect or engineer employed by the Owner as architect or engineer of record for the Project and its consultants.

  • Standard Specifications means a compilation in book form of specifica- tions approved for general application and repetitive use;

  • Plant means the machinery and apparatus intended to form or forming part of the Works.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Ethanol means a high octane gasoline blend stock that is used to make various grades of gasoline.