Consulting Services
Strain Selection & Banking
Microbial Strain Development and Characterization
Identification of GMP Cell Banking Laboratories
CMC Documentation and Support
Management of GMP Master Cell Bank Production & Testing
Identification of GMP Cell Banking Laboratories
CMC Documentation and Support
Management of GMP Master Cell Bank Production & Testing
Process & Facilities
Process Development: Upstream and Downstream for proteins and plasmid DNA
Scale-up from R&D to Clinical and Beyond
Facility Design Support, Including Critical Equipment and House Systems
Capital Expenditure and Manufacturing Costs
Scale-up from R&D to Clinical and Beyond
Facility Design Support, Including Critical Equipment and House Systems
Capital Expenditure and Manufacturing Costs
CMOs & Equipment
Technology Transfer
CMO Selection and Management
Production Planning & Scheduling
Key Process Equipment Identification and Sourcing
CMO Selection and Management
Production Planning & Scheduling
Key Process Equipment Identification and Sourcing
Fill/Finish & Contract Testing Labs
Fill/Finish CMO Selection and Management
Analytical Testing and Development
Identification of Contract Testing Labs
Review of Batch Records and Analytical Data
Analytical Testing and Development
Identification of Contract Testing Labs
Review of Batch Records and Analytical Data