Lonza Process definition

Lonza Process means Lonza's pre-existing proprietary manufacturing process for proteins that Lonza used to manufacture Bulk Drug under the January 2004 Agreement and that Lonza intends to use to manufacture Bulk Drug under this Agreement, as such process may be improved, changed or modified from time to time in accordance with the terms of this Agreement. The Lonza Process is a part of the Manufacturing Process.
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Lonza Process means the proprietary process of Lonza, including any modifications and improvements, which is used for the manufacture of the Product hereunder;
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Examples of Lonza Process in a sentence

  • The Lonza Process in effect as of the date of this Agreement bears ***.

  • Lonza Process Development and Quality Control personnel will perform the study as described in the attached study plan.

  • Lonza agrees that it shall make available to Omeros a license for purchase of Lonza’s proprietary feeds from Third Party suppliers or Lonza and to use the Lonza Process in connection with nonclinical and in vivo human clinical research and development, manufacture, marketing and sales and commercialization purposes (a “Proprietary Feed License”).

  • Lonza Process Development (PD) personnel will perform the study as described in the attached study plan.

  • The study will be performed by Lonza Process Development and/or Quality Control personnel, except for the execution of the [***] assays performed by VBL; assays will be performed under GLP conditions and documented in laboratory notebooks.

  • The study will be performed by Lonza Process Development and/or Quality Control personnel, except for the execution of the [***] performed by VBL; assays will be performed under GLP conditions and documented in laboratory notebooks.

Related to Lonza Process

  • RFP Process or “Bidding Process” means the process governing the submission and evaluation of the Bids as set out in the RFP itself;

  • 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 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.

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

  • 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.

  • Licensed Process means a method, procedure, process, or other subject matter whose practice or use is Covered By any claim or claims included within the Patent Rights or uses Technology Rights.

  • 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.

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

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

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • API means American Petroleum Institute.

  • 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.

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Hemp products means all products made from industrial hemp,

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Cell Line means a mammalian cell line that is developed using the Selexis Technology.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.