Stage 5: Purification Process Development Sample Clauses

Stage 5: Purification Process Development. 2.2.1. Pfenex shall develop a cGMP ready downstream purification process.
Sample 1Sample 2
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Stage 5: Purification Process Development. Pfenex shall examine, choose, and optimize a final method for [*] • The primary recovery procedure shall produce material which can be subsequently purified to meet product quality and safety specifications required for human use when produced under cGMP conditions. • Pfenex shall select and submit an optimal method to SAIC for review and approval. • Document shall also contain, at a minimum, methods examined, rational for method selected, and copies of the raw data. • Pfenex shall develop a downstream purification process based on lessons learned from Stage 2A (CSP research-grade purification strategy). • In-process recovery of CSP shall be calculated and monitored. • Pfenex shall utilize a buffer system that is suitable for the solubility and stability of the purified CSP; and that the buffer system shall meet product quality and safety specifications required for human use when produced under cGMP conditions. • Pfenex shall summit the developed purification process procedures and protocols to SAIC for review and approval before moving forward to engineering run (Stage 7). • Document shall also contain, at a minimum, processes examined, rational for processes selected, and copies of the raw data. • Pfenex shall ship all purified CSP generated during development to a SAIC designated facility; however, Pfenex may retain up to 10% of the material produced if necessary.
Sample 1
Stage 5: Purification Process Development. Pfenex shall examine, choose, and optimize a final method for [*] • The primary recovery procedure shall produce material which can be subsequently purified to meet product quality and safety specifications required for human use when produced under cGMP conditions. • Pfenex shall select and submit an optimal method to SAIC for review and approval. • Document shall also contain, at a minimum, methods examined, rational for method selected, and copies of the raw data. • Pfenex shall develop a downstream purification process based on lessons learned from Stage 2A (CSP research-grade purification strategy). [*] 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. • In-process recovery of CSP shall be calculated and monitored. • Pfenex shall utilize a buffer system that is suitable for the solubility and stability of the purified CSP; and that the buffer system shall meet product quality and safety specifications required for human use when produced under cGMP conditions. • Pfenex shall summit the developed purification process procedures and protocols to SAIC for review and approval before moving forward to engineering run (Stage 7). • Document shall also contain, at a minimum, processes examined, rational for processes selected, and copies of the raw data. • Pfenex shall ship all purified CSP generated during development to a SAIC designated facility; however, Pfenex may retain up to 10% of the material produced if necessary.
Sample 1

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