Process Development definition
Process Development means all process development activities undertaken with respect to Products, including without limitation activities related to development and optimization of cell lines, expression systems, reagents, upstream process, downstream process, protein modification, development of the Manufacturing process, process scale-up, process characterization, and process validation for bulk drug substance and final dosage forms of the Products and their related placebos.
Process Development means all process development activities undertaken with respect to the Product, including activities related to [***]. “Process Development Costs” means all costs invoiced by Third Parties to Coherus and/or its Affiliates for Process Development activities after the Effective Date directly resulting from any Process Development efforts as set forth in the Process Development Plan or otherwise approved by the JSC. Process Development Costs shall include [***], such as [***]. For the avoidance of doubt, the term ‘Process Development Costs’ shall include [***].
Process Development means all process development activities undertaken with respect to the Product, including activities related to [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Examples of Process Development in a sentence
The Client acknowledges that the activities as outlined in the SOW or this Agreement to be undertaken by Kemwell of the Process Development phase is experimental in nature and that no favourable or useful result can be assured by ▇▇▇▇▇▇▇.
Kemwell shall own any: (a) mechanical and technical trouble-shooting knowhow generally arising in the provision of the Services and carried out solely by Kemwell on non-Client Material, not being in the nature of Improvements to the Process Development, or (b) Improvements to Kemwell’s Pre-Existing IPR arising out of the provision of Services (for avoidance of doubt, this shall not include any Improvements made to Process Development) (each, a “Kemwell Invention”).
More Definitions of Process Development
Process Development means the period commencing with a processing run using the Working Seed and ending on Validation;
Process Development means, with respect to a product, all process development, process improvements, manufacturing scale-up, qualification and validation and quality assurance/quality control with respect to such product.
Process Development. The method for manufacture, harvesting and purification of the Product comprising of Upstream Process and Downstream Process as described herein; “Upstream Process” shall mean the entire process from early cell isolation and cultivation, to cell banking and culture expansion of the cells until final harvest (termination of the culture and collection of the live cell batch); “Downstream Process” shall mean the bioprocess where the cell mass from the Upstream Process are processed to meet purity and quality requirements. Downstream Processing includes cell disruption, a purification section, a polishing section, analysis of final product, formulation and storage; [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. “Certificate of Analysis” Certificate of analysis form issued by Kemwell and confirming that the Product belonging to each Batch to which the certificate relates, meets the applicable Specifications (including the results of analysis and testing of such Product), cGMP (in the case of cGMP Batches), Applicable Laws and such other criteria as identified on the certificate, in a form agreed to by the Client;
Process Development shall be deemed to be initiated, with respect to a particular TA Library, at such time as synthetic feasibility studies used to define an efficient synthetic process for production of such TA Library have been commenced.
Process Development means the exploration, identification, development and scale-up, pursuant to a Statement of Work, of (i) one or more new or improved Synthetic Pathways for manufacturing OLED Chemicals in quantities sufficient for supply on a commercial scale and on a cost-effective basis, including any processes intended to qualify as Validated Processes; (ii) new or improved Materials Specifications for such OLED Chemicals; and (iii) new or improved analytical methodologies, data and data analyses for characterizing such OLED Chemicals.
Process Development means the conduct by Paragon of activities to develop, confirm and/or refine processes for producing the Product and/or activities to develop and/or scale-up a Manufacturing Process suitable for cGMP manufacture of the Product.
Process Development means the development, qualification, validation and scale-up of the process to manufacture the Product, and any analytic development and Product characterization with respect thereto, beginning with final clone selection and upstream process development and terminating upon the completion of the process scale up activities prior to tech transfer to a CMO, in each case, as described in the CMC Plan, as such CMC Plan exists on upon the Effective Date.