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Engineering Services ______________________ Amgen, Inc. Objective: To reduce the risk of cell culture contamination and ensure new product introduction (NPI) success. Results: - Conformance lots proceeded on schedule with no recorded contaminations.
- This work was scheduled within a very tight 3 month window, between clinical and conformance lots. The work was completed under budget.
APECS managed engineering studies, conceptual/schematic/detailed design, implementation, and validation. Modifications were made to bioreactor equipment, instrumentation and automation control systems to reduce contamination risk and improve operational run time. APECS' role included obtaining and controlling the budget, managing sub-consultants, construction trades, and validation contractors.
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