Small Molecule Bioanalysis

Industry Leading Services for your Drug Development Journey 

You have access to our highly experienced bioanalytical team that will help you move your drug candidate to the next milestone. WuXi AppTec’s bioanalytical team will customize an approach that meets your dynamic needs, from study design to regulatory submission.

Key Highlights

  • Over 200 validated non-proprietary methods
  • Over 40 validated new methods for proprietary/innovator molecules each year
  • State-of-the-art mass spectrometry platforms with UHPLC-MS/MS capabilities
  • Over 500,000 sample analysis capacity per year
  • Automated and semi-automated high throughput capable systems including Janus®, TomTec® CyBio®-SELMA
  • 21 CFR Part 11 compliant validated systems; Analyst®, MassLynx™, Watson LIMS™

Download our Small Molecule Bioanalysis Brochure

Having the right bioanalytical strategy will help you make informed decisions faster. WuXi AppTec’s bioanalytical team understands what it takes to advance innovative therapies from discovery through preclinical to IND and beyond.

Industry-Leading Services for Your Drug Development Journey

LC-MS/MS Quantitation of Peptides & Proteins

Rapid Method Development

  • 2-4 weeks for peptides
  • 4-6 weeks for proteins

Extensive Experience

  • Resolve non-specific binding
  • Sensitivity tune-up
  • Trypsin digestion conditions
  • Microelution solid phase extraction (SPE) optimization

Diversified Peptides & Proteins

  • Different species and matrices
  • Hybrid Immunoaffinity LC-MS

Fast Synthesis Capabilities

  • 2 weeks turnaround time
  • Synthesize surrogate peptide
  • Synthesize SIL-IS

Extensive Experience for Diverse Small Molecule Compound Classes

  • Common new chemical entities (NCE)
  • Polar/non-polar and low molecular weight analytes
  • Endogenous analytes

Proven Expertise Across Species & Matrices

Comprehensive Quality Management System

State-of-the-Art Instrumentation to Rapidly Deliver High-Quality Scientific Results

  • 70+ UPLC™-MS/MS instruments globally
  • SCIEX API Triple Quad™ 4000/5000/5500/6500/6500+
  • Waters Xevo® TQ-S
  • Waters UPLC™/Shimadzu HPLC/Agilent HPLC/Shimadzu UHPLC
  • Fully automatic LC method scouting system
  • PerkinElmer Janus® liquid handling system
  • TomTec® liquid handling system

Integrated Bioanalytical Service for Global Submissions

  • GLP/non-GLP bioanalytical facilities
  • Central laboratory services – safety lab and clinical kits (China)
  • Innovator and generic drug bioanalytical support
  • Clinical and preclinical study support
  • Extensive experience in supporting bioanalytical studies for global regulatory submissions
  • Strong regulatory audit history from U.S. Food and Drug Administration (FDA), Organisation for Economic Co-operation Development (OECD), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA) and National Medical Products Administration (NMPA) with no major findings
  • Successfully filed Investigational New Drug (IND)/New Drug Application (NDA) packages with major regulatory agencies
  • Drug Enforcement Agency inspected, state licensed for radio-activity use (U.S.)