Services
-ADA methodology development and validation
-Nab methodology development and validation
-Multi-level immunogenicity sample analysis
-Viral activity analysis
-Provide various forms of target interference and drug interference solution strategies.
-Adequate communication and regulatory interpretation by CDE

Project Experience
- PD-L1/ PD-1, PCSK9 and other 20+ target monoclonal antibody products
- Dual antibody/dual target products such as PPD-L1/TGF-β, HER3/NRG-1, etc.
-ADC products such as HER2-DM1, HER2-ER301, etc.
- 10+ proteins and fusion proteins such as VEGF fusion proteins and PEG-uricase.
-AAV vector gene therapy products
-HSV, Adv and other oncolytic viral products
-Cell therapy products such as CAR-T
-Nucleic acid drugs such as siRNA.

Validated independent intellectual product analysis platform
Anti-AAV9 total antibody analysis platform
Anti-AAV9 neutralizing antibody analysis platform