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.
Cost structure and competitiveness (Capex and Opex), media cost and benchmarking, scalability and production.
Process development and optimization support (equipment specifications, costing evaluation, and system integration).
Comparative Techno-Economic Analysis of cultivated meat production.
Cost structure and competitiveness (Capex and Opex), media cost and benchmarking, scalability and production.
Cost structure and competitiveness (Capex and Opex), media cost and benchmarking, scalability and production.
Evaluate production facility scenarios considering Capital Expenditures (Capex) and Operational Expenditures (Opex), along with timelines, advantages, and disadvantages of the existing facility, retrofitting a potential selected facility, and/or new facility.
Cost Structure and Competitiveness (Capex and Opex), Media Cost and Benchmarking, Scalability and Production. Also Service provider for on-site due diligence project
Project and Engineering Management.
Process, C&Q engineering, technology transfer, validation study and project management system.
PFD, PIDs, 3D layout, piping isometric drawings, facilities utilities estimation & sizing.
Bioreactors system 3D model generation.
Fermentation system design includes 3D design, PIDs, and equipment list.
Process and C&Q engineering.
Medium filtration and sterilization system.
Technical Staff Augmentation.
PFD, PID, and process color flows.
Technology transfer and quality assurance services.
Process detail design, C&Q engineering and project management services.
Process engineering and commissioning activities.
Quality documentation package and drafts of Standard Operating Procedures compliant with cGMP norms.
Review existing quality documents and prepare comments, revise documents based on clarification and discussion, and control and manage deliverable schedule.
Contamination control strategy and risk assessment document, and calibration management.