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 30 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.
Raw Material Testing
Biosafety Testing
Raw Material Testing
Owing to regulatory requirements for the whole-process control of biologics, greater attention is being paid to various tests of raw materials. Hengyu biotech provides a full range of testing services for microorganisms, virus and residue to ensure the safety and reliability of raw materials.
Assay items
- Sterility Testing
- Bioburden assay
- Mycoplasma detection assays
- Residual DNA detection assays
- Endotoxin detection assays
- Exogenous viral contamination detection assays
Sample types for analysis
- Serum
- Cell Culture Medium
- Various reagents
- Animal-derived cells
- Animal-derived medical device
- Matrix for antibody purification
- Non-serum samples
- Culture environment sampling