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
• LC/MS/MS Method Development &Validation
• Immunoassay Method Development &Validation
• Small Molecule Drug Sample Analysis
• Peptide & Protein Drug Analysis
• Synthesis of Reference Standard & Stable Labeled Internal Standards
• Biomarkers

• Vaccine
• Immunogenicity

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)