Working Cell Banks definition

Working Cell Banks means Cell Suspension Subcultured from Urokinase Kidney Cells, Frozen Sub-2, Code 48647 as Schedule 2.1(c).
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Working Cell Banks means those Third Party working vero cell banks licensed to Seller under the Key License Agreement and held for use for initiation of production cell cultures for the Product on a lot by lot basis and having the lot numbers set forth on Schedule J.
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Working Cell Banks means NPS’ working cell banks containing the host cells (with the plasmid incorporated therein) used in the fermentation process for the production of recombinant glycine2-human glucagon-like peptide-2(ALX-0600(Teduglutide)) as a secreted material in the fermentation culture broth and as a fusion peptide for the inclusion bodies in the host cell. The Working Cell Banks for the secreted process are designated [*] and are generated from the Master Cell Bank for such process. The Working Cell Bank for the [*] Process is designated [*] and is generated from the Master Cell Bank designated [*].
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Examples of Working Cell Banks in a sentence

  • Information on the cell banking system; quality control activities and cell line stability during production and storage (including procedures used to generate the Master and Working Cell Bank(s) should be provided in detail.

  • Information on the cell banking system; quality control activities and cell line stability during production and storage (including procedures used to generate the Master and Working Cell Bank(s) should be provided in details.

  • Conduct process validation studies to support manufacture of pertuzumab from Working Cell Banks by a modified process.

  • The cell bank system generally consists of two tiers: an MCB; and Working Cell Banks (WCBs) generated from the MCB for product manufacturing (although a WCB may not have been generated prior to Phase 1 studies).

  • Master Cell Banks (MCB) and Working Cell Banks (WCB) should be well characterized and a description of how the bank is manufactured and tested should documented.

  • The concept of a two-tiered cell bank, in which the MCB which is used to generate Working Cell Banks (WCBs), is generally accepted as the most practical approach to providing a supply of cell substrate for continued manufacture of the product.

  • The multi- product Alpha facility operates stirred tank reaction vessels, ranging from 10l to 500l, and also uses perfusion technology - this results in a 20 times increase in productivity per reaction vessel.Alpha Biologics also develops stable cell lines and Master and Manufacturing Working Cell Banks prior to the start of cGMP manufacture.

  • Position PapersThe following positio n papers have been adopted by CVMP:• Establishment of MRLs for milk in relation to the daily intake by children (EMEA/CVMP/391/02).• Re-establishmen t of Working Seeds and Working Cell Banks using TSE co m plian t materials (EMEA/22314/02).• Maxim u m In-Use Shelf-Life for Medicated Drinking Water (EMEA/CVMP/1090/02).VICH GuidelinesThe Committee adopted the follow-allowing herbal practitio ners to extem poraneously dispense Hyper- icum perforatum L.

  • Production of the recombinant protein should be based on well-defined MCB and Working Cell Banks (WCB).

  • WCB (Working Cell Banks) importation in to Singapore requires an Import Permit issued by Agri-Food and Veterinary Authority of Singapore.

Related to Working Cell Banks

  • Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto.

  • Large Facility Interconnection Procedures or “LFIP”) shall mean the interconnection procedures applicable to an Interconnection Request pertaining to a Large Generating Facility that are included in Attachment X of the NYISO OATT. Standard Large Generator Interconnection Agreement (“LGIA”) shall mean this Agreement, the form of interconnection agreement applicable to an Interconnection Request pertaining to a Large Generating Facility, that is included in Attachment X of the NYISO OATT. System Deliverability Upgrades shall mean the least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements, to make the modifications or additions to Byways and Highways and Other Interfaces on the existing New York State Transmission System and Distribution System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Deliverability Interconnection Standard at the requested level of Capacity Resource Interconnection Service. System Protection Facilities shall mean the equipment, including necessary protection signal communications equipment, required to (1) protect the New York State Transmission System from faults or other electrical disturbances occurring at the Large Generating Facility and (2) protect the Large Generating Facility from faults or other electrical system disturbances occurring on the New York State Transmission System or on other delivery systems or other generating systems to which the New York State Transmission System is directly connected. System Upgrade Facilities shall mean the least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements, to make the modifications to the existing transmission system that are required to maintain system reliability due to: (i) changes in the system, including such changes as load growth and changes in load pattern, to be addressed in the form of generic generation or transmission projects; and (ii) proposed interconnections. In the case of proposed interconnection projects, System Upgrade Facilities are the modifications or additions to the existing New York State Transmission System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Minimum Interconnection Standard. Tariff shall mean the NYISO Open Access Transmission Tariff (“OATT”), as filed with the Commission, and as amended or supplemented from time to time, or any successor tariff. Trial Operation shall mean the period during which Developer is engaged in on-site test operations and commissioning of the Large Generating Facility prior to Commercial Operation.

  • Outdoor cultivation means the cultivation of mature cannabis without the use of artificial lighting or light deprivation in the canopy area at any point in time. Artificial lighting is permissible only to maintain immature plants outside the canopy area.

  • Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.

  • Business Line is an Embarq-owned switched access line used to serve a business customer, whether by Embarq or by a competitive LEC that leases the line from Embarq. The number of Business Lines in a Wire Center shall equal the sum of all Embarq business switched access lines, plus the sum of all UNE loops connected to that Wire Center, including UNE loops provisioned in combination with other unbundled elements. Among these requirements, Business Line tallies (1) shall include only those access lines connecting end-user customers with Embarq end-offices for switched services, (2) shall not include non-switched special access lines, (3) shall account for ISDN and other digital access lines by counting each 64 kbps-equivalent as one line. For example, a DS1 line corresponds to twenty-four (24) 64 kbps-equivalents, and therefore to twenty-four (24) “Business Lines.”

  • Aquaculture facility means the same as that term is defined in Section 4-37-103.

  • Cannabis cultivation facility means a person that:

  • Generating Facility means the Generating Unit(s) comprising Seller’s power plant, as more particularly described in Section 1.02 and Exhibit B, including all other materials, equipment, systems, structures, features and improvements necessary to produce electric energy and thermal energy, excluding the Site, land rights and interests in land.

  • Cannabis processing facility means a person that:

  • Health facility means the medical college and hospital or the teaching hospital or the district/ sub-division etc. hospital to which the goods and/ or services under the contract shall be supplied.

  • Generation Interconnection Feasibility Study means a study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) in accordance with Tariff, Part IV, section 36.2.

  • Marijuana cultivation facility means an entity licensed to cultivate, prepare, and package marijuana and sell marijuana to retail marijuana stores, to marijuana product manufacturing facilities, and to other marijuana cultivation facilities, but not to consumers.

  • Generation Interconnection Facilities Study means a Facilities Study related to a Generation Interconnection Request.

  • Busy Line Verification (BLV) means a service whereby an End User requests an operator to confirm the busy status of a line.

  • Processing facility means an establishment that prepares, treats, or converts tangible personal property into finished goods or another form of tangible personal property. The term includes a business engaged in processing agricultural, aquacultural, or maricultural products and specifically includes meat, poultry, and any other variety of food processing operations. It does not include an establishment in which retail sales of tangible personal property are made to retail customers.

  • Project Assets means all physical and other assets relating to (a) tangible assets such as civil works and equipment including foundations, embankments, pavements, road surface, interchanges, bridges, culverts, road over-bridges, drainage works, traffic signals, sign boards, kilometre-stones, [toll plaza(s)], electrical systems, communication systems, rest areas, relief centres, maintenance depots and administrative offices; and (b) Project Facilities situated on the Site;

  • Cell Line means the cell line, particulars of which are set out in Schedule 1.

  • Customer Interconnection Facilities means all facilities and equipment owned and/or controlled, operated and maintained by Interconnection Customer on Interconnection Customer’s side of the Point of Interconnection identified in the appropriate appendices to the Interconnection Service Agreement and to the Interconnection Construction Service Agreement, including any modifications, additions, or upgrades made to such facilities and equipment, that are necessary to physically and electrically interconnect the Customer Facility with the Transmission System.

  • Marijuana testing facility means an entity licensed to analyze and certify the safety and potency of marijuana.

  • Transit-oriented facility means a facility that houses a transit station in a manner that promotes transit ridership or passenger rail use.

  • Interconnected Reliability Operating Limit or “IROL” shall mean the value (such as MW, MVAR, Amperes, Frequency, or Volts) derived from, or a subset of, the System Operating Limits, which if exceeded, could expose a widespread area of the bulk electrical system to instability, uncontrolled separation(s) or cascading outages.

  • Busy Line Verification (BLV means a service whereby an End User requests an operator to confirm the busy status of a line.

  • 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.

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

  • Farming operation means raising, cultivating, propagating, fattening, grazing, or any other farming, livestock, or aquacultural operation.

  • final consumer means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.