Services
Cell Therapy and Protein product manufacturing, characterization, storage, and distribution
Cell Therapy and Protein product process development, consultation, and support
- Batch record creation and refinement
- Develop manufacturing SOPs
- Quality manufacturing process and analytical methods
- Build and activate Bills of Materials and SOPs for orders to manufacture, collect, process, and release products to patients
Quality Control (assays and testing)
- Broad analytical platform that can be tailored for specific projects
- Best in class environmental monitoring program
Quality Assurance
- Robust electronic Quality Management System with cross-functional Quality Council
- Dedicated Quality staff
- Documented release of each cGMP suite after cleaning and change over for each manufacturing campaign
- Equipment qualification program
- Vendor qualification program
Regulatory (FDA) compliance and support
- Assist with pre-IND FDA meetings
- Assist with Chemistry, Manufacturing, and Controls (CMC) section of -IND preparation
- Audit and review procedures, processes, and test results
- Assist with labeling requirements
- Monitor product non-conformances
Clinical Protocol Support from Facility Medical Director
- Review clinical protocol
- Ongoing study management and problem resolution