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.
Cell Bank Testing
Quality Control of Gene and Cell Therapy Products
Cell Bank Testing
In response to the ever increasing emphasis on the safety evaluation of biologics prepared from specific human or animal cell lines, hengyu biotech provides identity, sterility inspection, mycoplasma Test, endogenous/exogenous viral factor contamination detection and other services with reference to ICH Q5A (R1), Chinese Pharmacopoeia (2020 Edition, Volume III) "Preparation and Quality Control of Animal Cell Substrates for Production and Assay of Biological Products", and other relevant regulations. Hengyu biotech advantages include excellent project management, the ability to solve customer pain points faster under the same technical conditions, and the ability to develop quick alternative assay to meet customer needs while complying with regulatory requirements.
Full Scale of Biosafety testing Services
- Identity & analysis
- Sterility inspection
- Mycoplasma detection
- Endogenous/exogenous viral factor contamination detection
- Cell oncogenicity and tumorigenicity research
Sample types for analysis
- PCB, RCB, MCB, WCB, EOPC and UPB (live cells, supernatant, suspension and medium)
- Various types of stem cells