Downstream Process definition

Downstream Process means that part of the Developed Process that follows the Upstream Process starting with (and expressly including) the following process step: loading of the first chromatographic column and expressly including all chromatographic purification and final conditioning of the Product.
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Downstream Process means that part of the Developed Process that follows the Upstream Process, starting with (and expressly including) the following process step: [***].
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Downstream Process means 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;
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Examples of Downstream Process in a sentence

  • LFB USA grants rEVO with an option to obtain a worldwide license under Downstream Process Manufacturing Rights and Fill and Finish Manufacturing Rights necessary to manufacture or have manufacture AAT Product.

  • If the termination or expiration was due to any reason other than by rEVO pursuant to Section 11.2.3.2 or by LFB USA pursuant to Section 11.2.3.1, LFB USA and rEVO shall negotiate a license to and technology transfer for the benefit of rEVO on Downstream Process Manufacturing Right and Fill and Finish Manufacturing Right that may be necessary for rEVO to manufacture the THIRD PARTY VIALED PRODUCT.

  • Upstream and Downstream Process Flow Diagrams for the production of the Blue Water influenza vaccine candidate are shown in Figure 1 and Figure 2.

  • Technology Transfer ***** o Fermentation Process Transfer o Downstream Process Transfer o Analytical Method Transfer o Analytical Support for Process Transfer ----------------------------------------------------------------- ----------------------------------------------------- ----------------------------------------------------------------- ----------------------------------------------------- III.

  • Project: Downstream Process Development Timeline: 30-60 days Cost: *** Start Date: Per MS Project Timeline · AVID will purify bulk filtrate supplied either by HYALOZYME or from the research bioreactor runs performed at AVID.

  • Without limiting the generality of the foregoing, the Licensee shall procure and maintain at its own expense all approvals, licenses, authorizations, permits and other rights necessary to the performance of its obligations under this Agreement and at all times conduct its business in a manner so as to not bring discredit upon the reputation or negatively impact the Licensor’s business with respect to the PPPS Backbone, any Existing Downstream Process, any Improved Downstream Process and the Licensor.

  • In cases where there are insufficient operators available to work overtime and the Company canvasses additional Downstream /Process Technicians as operators, those technicians will be utilized in a direct capacity.


More Definitions of Downstream Process

Downstream Process means [***];
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