Facility related design activities, generally in Concept design and basic engineering with costings.
Concept Layout Design of the facility
Basic and detailed design of 5 x 10k L Cell culture bioreactor trains, incl. 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 in China.
Facility related design activities, generally in Concept design and basic engineering with Novartis’s HAZOP revalidation (periodic review) efforts.
Liposome process Technology transfer to Scinai Facility
Comprehensive project plan with inputs from design, facility, qualification, regulatory to meet current standard cGMP and production requirements.
Concept Design for 1,000L 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)
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