Quotation for Qualification Campaign at 50g NPW scale Sample Clauses

Quotation for Qualification Campaign at 50g NPW scale. (in Euros) · Objective: Qualify the parameters defined as critical for both upstream and downstream for the preparation of BA-058 peptide. Lonza will run the qualification campaign at a scale of 50g NPW; however, the assembly and cleavage reaction that will lead to the crude will be performed at a scale of 180g API equivalent, since this is the minimum scale at which the process can be validated later. The assembly will be performed in a 20L SPPS reactor. Only part of the crude (50g NPW out of 180g NPW) will be purified on an LC150 HPLC column and lyophilized in a GT10 lyophilizer. The excess of crude will be stored and can be purified later. Excellent 18M stability data of the crude are currently available. The price is given for the first 50g NPW production (including the full cost of the crude at a scale of 180g NPW API equivalent), as well is for the later processing of the excess crude (without crude processing cost and per 50g NPW API): Quotation First 50 g NPW 50 g Price without cost of crude First 100 g NPW First 150g NPW Full 180g NPW Raw Materials [* ] [* ] [* ] [* ] [*] Production: · Crude (at scale of 180 g API equivalent) [* ] [* ] [* ] [* ] [*] · Purification and Lyophilisation [* ] [* ] [* ] [* ] [*] QC/QA Release [* ] [* ] [* ] [* ] [*] Total Quote 217,000 99,500 243,000 264,000 274,500 Price / g [* ] [* ] [* ] [* ] [*] · Lead time: 14 weeks · Deliverables: see point 8 · Following Lonza SOP a Development Manufacturing Report will be issued after qualification, considered as engineering batch. In case of no change between this batch and validation batches, this is possible after an equivalency report to use this batch as commercial supply. Moreover, this batch may be use for clinical trials as far as API specifications are met, as for C1 and C2 campaigns material.
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