The development of gene and cell therapy products and the CDMOs are very important to the R&D of innovative drugs. Based on years of experience in viral vector preparation and quality control, Hengyu biotech provides clients with a full range of vector characterization and process residue detection services as reliable quality assurance for quick IND applications and BLA large-scale production in the future for gene and cell therapy products.
Process Residue Detection
Quality Control of Gene and Cell Therapy Products
Process Residue Detection
As part of pharmaceutical quality control, cell- and gene-based therapy products need to be tested and analyzed for process-related impurities and contaminants. In general, the production process introduces such impurities, which can include plasmid, helper virus, and host cell residues.
Process Residue Detection
- Host residual protein detection
- Host residual DNA detection
- Endotoxin residue detection
- Residue detection of helper plasmid for packaging
- Antibiotic residue testing