Upstream Process definition
Upstream Process means that part of the Developed Process starting with (and expressly including) the following process step: first inoculation of a culture with the Developed Strain up to (but expressly excluding) the following process step: the loading of the first chromatographic column; for the sake of clarity the Upstream Process shall expressly include any fermentation, harvest and clarification of the culture broth.
Upstream Process means 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;
Upstream Process means that part of the Developed Process starting with (and expressly including) the following process step: first inoculation of a culture with the ▇▇▇▇▇▇ Strain up to (but expressly excluding) the following process step: the loading of the first chromatographic column. For the sake of clarity, the Upstream Process shall expressly include any fermentation, harvest and clarification of the culture broth.
Examples of Upstream Process in a sentence
Project: Upstream Process Transfer and Media Selection Timeline: 30 to 45 days Cost: *** Start Date: Per MS Project Timeline · HYALOZYME will transfer to AVID all available cell culture data available for the production cell line, however AVID recognizes that AVID will likely develop this information for HYALOZYME.
Project: Upstream Process Development Timeline: 30-60 days Cost: *** Process Steps: · AVID will perform one research run at 22.5 liter scale to verify cell growth, density, productivity and viability prior to shakedown run.