Robust Cell Therapy Quality Control for GMP Manufacturing
Our QC team works closely with our clients and internal teams to implement robust testing methods.
We understand that testing methods have a critical role in the life-cycle of the product. Our QC team provides testing support to all cGMP manufacturing programs.
Our QC services include:
- ICH/cGMP stability programs for clinical products
- Protocol and Study Development
- Pull Schedule
- Accelerated and long-term stability studies
- Standard cGMP testing for in-process and release performed at Cellipont
- Endotoxin
- Flow Cytometry
- Cell-based potency assays
- Replication Verification
- Cell count and viability
- Fill Volume
- Appearance
- PCR-based analytical assays
- Analytical method qualification, transfers, and validation
- Sample Management
- Environmental Monitoring of GMP facilities
- Management of Outsourced assays
Contact us today at [email protected] to learn more about our QC services.