Bioanalytical Services

WuXi AppTec offers comprehensive and FDA/OECD/SFDA GLP-compliant bioanalysis services to support preclinical and clinical development for small molecule drugs, biologics, vaccines and PD biomarkers.

Highlights

  • GLP facility established in 2005 with over 180 experienced scientists
  • Data accepted by worldwide health authorities
  • Strong logistical support for receiving material and biological samples sent from anywhere in the world
  • Selected as preferred vendor for 6 of the top 20 international pharmaceutical companies
  • Validated Watson 7.2 LIMS for sample and data management
  • Operation in Philadelphia and Shanghai for global support
  • US FDA inspected and SFDA/OCED member GLP-certified

Capabilities

State-of-the-Art Equipment

  • Gyrolab XP
  • MSD Sector Imager 6000
  • Luminex 200
  • MoleculeDevices M2/M5 reader
  • AB Sciex API 5000 Q Trap/Waters Xevo G2 QTOF
  • API 4000/5000/5500 LC/MS/MS
  • Waters UPLC/Agilent HPLC/Shimadzu HPLC/Leap CTC autosampler
  • Tecan EVO automated ELISA workstation
  • Hamilton Microlab Star workstation

LC/MS/MS Method Development &Validation

  • Development/transfer and optimization of methods for quantitation of drug substances in biological matrices
  • Over hundreds of nonproprietary method validated and available for use
  • Quick validation in Philadelphia lab to support a potential study

Immunoassay Method Development &Validation

  • Immunogen preparation
  • Antibody production and labeling (ABGENT – US; WuXi Biology Department - China)
  • Assay development/transfer and validation

Small Molecule Drug Sample Analysis

Study Support Capabilities:

  • Clinical trials conducted in any countries around the world
  • GLP pre-clinical studies
  • Generic BE trials

Peptide &Protein Drug Analysis

Study Support Capabilities:

  • Immunoassay and LC/MS/MS
  • GLP pre-clinical studies and global clinical studies
  • BE trials

Synthesis of Reference Standard & Stable Labeled Internal Standards

WuXi’s internal chemistry and radio-synthesis lab allow us to offer the advantage of in-house synthesis of reference standards and internal standards with rapid turnaround time and lower cost.

Biomarkers

  • Clinical Chemistry
  • Soluble Biomarkers
  • Histology/Immunology
  • Genomics
  • qRT-PCR

Vaccine Analysis

  • Multi-valent vaccine assay
  • Multi-serotypes antibody assay
  • High through-put automation

Immunogenicity

  • Screening assay
  • Confirmatory assay
  • Titration assay
  • Cell-based neutralizing antibody detection

Please contact us for more information at
BAS_US@wuxiapptec.com (US operation)
BAS_China@wuxiapptec.com (China Operation)