Batch Run definition

Batch Run means the production and purification process performed by ImmunoGen to generate a Batch of Drug Substance pursuant to this Agreement.
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Examples of Batch Run in a sentence

  • The Parties acknowledge that these Draft Specifications are subject to change with the collection of Batch Run manufacturing data.

  • ImmunoGen shall issue a written request for BIWA4 to BI Pharma (a "Shipment Order") including, but not limited to, amount and delivery date not later than [ * ] prior to the scheduled initiation of the Batch Run.

  • ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the negligence or misconduct of ImmunoGen.

  • After approval of registration committee, the minutes are prepared which are to be approved by Chairman of Registration Committee and thereafter, intimation was sent to the applicant that the file has been cleared.

  • The foregoing notwithstanding, the Parties acknowledge that there may be Batch Run failures not attributable to either Party.

  • The following students cannot apply for LOA: Students with unpaid classes either obtained through the Batch Run or manual enlistment.

  • Sollecito, testing of Miss Kercher’s bra clasp in DNA Batch Run 5.

  • ImmunoGen shall issue a written request for BIWA4 to BI Pharma (a “Shipment Order”) including, but not limited to, amount and delivery date not later than [ * ] prior to the scheduled initiation of the Batch Run.

  • Some views are optimistic, holding that this was the case in Hong Kong after the crisis when new bond issues ‘partially filled the gap’ in financing that opened in 1998-99 when total bank lending fell.42 Yet the amount raised was modest (representing in 1999 only 13.7 per cent of that year’s fall in domestic lending) and the buyers of new bonds were mainly banks.

  • Example: Starting a Batch Run This example demonstrates how to start a batch run that compiles a COBOL source element.

Related to Batch Run

  • Batch Record means the production record pertaining to a Batch.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • API means the American Petroleum Institute.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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;

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Acceptance Test Document means a document, which defines procedures for testing the functioning of installed system. The document will be finalized with the contractor within 7 days of issuance of the Letter of Award.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Manufacturing Process means any process for—

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • QA means Quality Assurance.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalised Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • 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.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • 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.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.