Xiao-Yan Cai, PhD
CEO & Co-Founder
30 Years of Large Molecule Bioanalysis Experience
- Former Director of Bioanalytical Divisions for Biologics at Merck.
- Former Global Head for Large Molecule Bioanalysis Division at WuXi AppTec.
Successfully Supported Merck’s anti-PD1 (a.k.a. Keytruda) BA methods development & validation & study sample testing for preclinical and clinical programs（PK, ADA, NAb) ，core member for the initial BLA filing for Keytruda US approval.
Opinion leader for Biosimilars bioanalysis: numerous publications were used as guidance white papers for the bioanalysis industry to support biosimilar comparability studies.
AAPS key committee member for biosimilar bioanalysis sub-teams
Key Author of a number of white papers on bioanalysis, especially for biosimilars (i.e. Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development Bioanalysis 4(17), 2169-2177 (2012)); widely cited as the industry’s guide for biosimilar bioanalysis to support comparability studies.
Dongbei Li, PhD
U.S. Site Head & Co-Founder
20+ Years’ experience in pharmaceutical R&D and bioanalysis at Amgen, Pfizer, and WuXi AppTec.
Built WuXi AppTec Large Molecule Bioanalysis services: 80+ staff team.
The first author of xMAP Array Microspheres-Based Stem-Loop Structured Probes as Conformational Switches for Multiplexing Detection of miRNAs, Analytical chemistry 86:10148-56 (2014)
Co-author of Biological Sample Analysis Method Validation Guidelines, China Pharmacopoeia 2015.
Co-author of Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team, AAPS Journal 16 (2): 221-5 (2014)
Co-author “Use of Optical Biosensor Technology to Study Immunological Cross-Reactivity between Different Sulfonamide Drugs” Analytical Biochemistry 300, 177-184 (2002)
China Site Head & Co-Founder
Former Director of the biological analysis department at WuXi AppTec, Member of TFM with 10+ years large molecule bioanalysis experience; Responsible for overseas business and domestic biological similar business.
Led a team of 50+ people and established long-term good cooperative relations with many international pharmaceutical companies (i.e. Novartis, Squibb, Eli Lilly, Pfizer, Merck, etc.), supported 200+ international multi-center clinical trials of new biological drugs, including 50+ international multi-center phase III clinical trials;
Years of successful experience in audit of domestic and foreign drug regulatory agencies (CFDA, FDA, EMA, OECD, etc.). Provide PK, ADA, and NAb data for the approval of multiple international heavyweight new drugs (Cosentyx, Keytruda, Opdivo, Yervoy, etc.)
Standing director of CBF Youth Club was invited to give academic reports in CPSA and CBF many times, including “Key Considerations for the Regulated Immunogenicity Assessment in Support of Clinical Trials”.
Our core technical team consists of 5-13 years of experience in large molecule bioanalysis. They have rich technical experience and have had long-term collaboration with world-class pharmaceutical companies. The team have passed multiple FDA, EMA, OECD, The CFDA audits and has supported hundreds of domestic and overseas multi-site clinical trials.
The company currently operates simultaneously in Shanghai (CN), Ningbo (CN) and New Jersey (US), with 120+ employees and several core business platforms (FACS/PCR/ELISA/MSD/EnVision/flow cytometry), which can support sample analysis of more than 100 clinical projects, covering peptides, recombinant proteins, fusion proteins, Monoclonal antibodies, bispecific antibodies, nanobodies, ADCs and CAR-T and other biological macromolecules.