Clinical Bioanalysis

As part of our integrated offering, the Laboratory Testing division supports the clinical development of small and large molecule drugs with bioanalytical services covering phase I-IV clinical trials. Our clinical Bioanalytical Services Unit provides study support for both generic/biosimilar and innovator drugs, with sample management for global clinical trials in compliance with GCLP standards.

Bioanalytical Services Supporting Clinical Studies

+ LC-MS/MS and LBA platforms for small and large molecules
+ Generic and innovator study support
+ Clinical PK sample analysis and PK calculations
+ Radiolabeled hAME sample analysis and study support
+ Clinical metabolite ID and (radio) profiling: 3H and 14C
+ MIST cross-species metabolite comparison
+14C-labeled and 19F-NMR mass balance
+ Soluble, genetic, cellular and tissue biomarker analysis

LC-MS/MS Platform

+ 400+ GLP validated assays
+ 120+ dedicated clinical bioanalytical team in Shanghai
+ 44,000 square feet of GLP lab space
+ 36 LC-MS systems
+ 40,000+ samples per month at peak time
+ 15 Method validations per month
+ 2,000+ clinical trials supported

Immunochemistry Platform

+ Pharmacokinetics (PK)
+ Immunogenicity (ADA)
» Screening assays
» Confirmatory assays
» Neutralizing Antibody (NAb) assays
+ Pharmacodynamics (PD) and exploratory biomarker
+ Clinical kits for clinical trial support in Shanghai
+ Reagent generation
+ Method development and transfer
+ GLP method validation and sample analysis
+ Fully validated LIMS system with audit trail for sample and data management

Abgent | A WuXi AppTec Company

View Abgent’s catalogue of antibody solutions, including reagent development and custom protein expression.