Facility related design activities, generally in Concept design and basic engineering with costings.
Concept layout design of the facility.
Basic and detailed design of the cell culture bioreactor trains includes the media prep, CIP, and harvest systems.
Commissioning and Qualification Plan (CQP) for facility, utilities, equipment, and analytical systems.
Basic design for a new biologics manufacturing facility.
Facility-related design activities, generally in Concept design and basic engineering, with the HAZOP revalidation (periodic review) efforts.
Liposome process technology transfer.
Comprehensive project plan with inputs from design, facility, qualification, regulatory to meet current standard cGMP and production requirements.
Concept design for a capacity cultured meat manufacturing plant.