Drug regulatory agencies in various countries require that the purification and production process of biological products extracted from human or animal tissues or body fluids, animal-derived monoclonal antibodies, and recombinant products expressed by eukaryotic cells must conduct virus clearance/inactivation validation in the application materials before clinical trial and production stage.
These studies can provide assurance that viral contaminants introduced by the starting material (or materials used in the manufacturing process) are not present in the final purified product to ensure the safety of biologics at both the clinical trial and the commercial production stage.
- ✔ Domestically produced virus clearance product as a cost-effective alternative to reduce production costs.
- ✔ Advanced and comprehensive instruments, along with a P2 laboratory, to meet virus clearance validation requirements.
- ✔ Robust GLP quality management standards to ensure data authenticity, integrity, and traceability.
- ✔ Professional technical team providing regulatory interpretation, technical support, and validation experiments.
● Domestic alternative virus removal products to reduce production costs;
● Advanced equipment and P2 lab to meet the requirements of VCS;
● Comprehensive GLP quality management standards to achieve data authenticity, integrity, and traceability;
● Professional technical team to provide regulatory interpretation, technical support and validation experiments.