Hengyu Biotech follows the GLP system to provide biosafety testing services with assurance at the phases of drug R&D and commercial production. Hengyu biotech services currently cover studies on viral clearance and inactivation studies, inactivation studies, Cell line characterization and Validation，and raw material testing. Hengyu biotech biosafety testing team consists of more than 90 professionals from industry-leading cell and virus preparation companies and biologics R&D institutions as well as first-class universities in China. Hengyu biotech has accumulated more than 10 years of experience in biosafety testing technology, and have completed more than 100 projects successfully.
Cell Bank Testing
Biosafety Testing
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 detection, 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