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Non-GLP Bioanalysis

Complete Services for Small- and Large-Molecule Drugs

WuXi AppTec offers a full range of Bioanalytical expertise to support both small- and large-molecule drug development, including biomarkers, immunogenicity and pharmacokinetic (PK) studies.

From method development and qualification to sample collection protocol design, optimized project workflows and state-of-the-art technology platforms for high-throughput research quality, our work meets the highest standards, providing Good Laboratory Practice (GLP) assays suitable for discovery and preclinical development.

Small-Molecule Drug Bioanalysis

Capabilities

  • Comprehensive solutions for a wide range of compounds including small molecules, biomarkers, peptides, proteins and drug carriers based on the LC-MS platform
  • Validation and continuous development of protein bioanalysis based on the LC-MS platform:
    • Awarded the National Institutes for Food and Drug Control (NIFDC) Certificate for “Biological sample analysis – Measurement of monoclonal antibody Bevacizumab concentration in monkey serum” in 2019
  • Quantitative detection of 100+ endogenous biomarkers in support of the treatment of metabolic disorders, cardiovascular disease and Alzheimer’s disease
  • Bioanalytical techniques for nucleotide antiviral compounds
  • Analytical capabilities for microsamples including volumetric absorptive microsampling (VAM, Mitra®), capillary tube sampling, dry blood spot, dry plasma spot and microdialysis
  • Quantitative capabilities > 700 peptides, molecular weight up to 15,000 Da
  • Bioanalysis of PEG-conjugated drugs, chiral & cis-trans isomers and ocular/skin samples

Instrumentation

  • WuXi AppTec was the first company in China to apply Apricot Designs Dual Arm and MPXTM-2/Shimadzu Nexera UHPLC-30A LC-MS/MS for exceptional high-throughput bioanalysis
  • UPLC™, UHPLC and high-throughput autosamplers:
    • Shimadzu Nexera UHPLC-30A
    • Waters ACQUITY™UPLC™
    • Waters ACQUITY™ UPLC™ I-Class PLUS
    • Waters Alliance HPLC
    • CTC Analytics Dynamic Load Wash
    • Apricot Designs Dual Arm (ADDA auto ampler system)
    • MPX™-2 Shimadzu Nexera UHPLC-30A
  • First-class triple quadrupole and high-resolution MS systems
    • SCIEX Triple Quad™5500+/6500+
    • SCIEX QTRAP® 6500
    • Thermo Scientific™ Q Exactive™ Plus
    • Thermo Scientific™ Q Exactive™ HF
    • Waters Xevo® G2-XS QTof™

 

Turnaround Time

  • Bioanalytical studies for discovery screening: 24hrs in vitro samples; 48-72 hrs. in vivo samples
  • Bioanalytical studies for IND application: <14 days (method validation according to U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) guidance)

Large-Molecule Drug Bioanalysis

You have access to a DMPK team that supports non-GLP bioanalysis of antibodies, bispecific antibodies, recombinant proteins, biosimilars, fusion proteins, peptides, antibody drug conjugates (ADC), PEGylated peptides and proteins, hormones, oligonucleotides, gene therapy products and vaccines.

Capabilities

  • Support for non-GLP bioanalysis of antibodies, bispecific antibodies, recombinant proteins, biosimilars, fusion proteins, peptides, antibody drug conjugates (ADC), PEGylated peptides and proteins, hormones, oligonucleotides, gene therapy products and vaccines
  • Validated in-house methods and reagent inventory:
    • Immunogenicity (ADA and neutralizing antibodies)
    • Pharmacokinetics
    • Single and multiplex biomarkers
    • Receptor occupancy and binding
    • Immunophenotyping: intra/extracellular, specific marker in organelle and intranuclear
    • qPCR
    • Hybridization ELISA
    • Enzyme Activity assay
    • Preparation of PBMC and RNA samples
    • In vitro assay for different stimulation
    • Biodistribution
    • General lymphocyte immunophenotyping, Th1/Th2 multiplex cytokine, chemokine and proinflammatory cytokine panel, myocardial damage and TDAR

Instrumentation

  • Flow cytometry (BD FACSCanto™ II and BD LSRFortessa™ Flow Cytometer)
  • SpectraMax® M2e/M5 with SoftMax® Pro GxP 5.4.1, or equivalent
  • MESO™ QuickPlex SQ 120 system
  • Tecan EVO® automated ELISA workstation
  • Hamilton Microlab® Star™ workstation
  • Bio-Tek® plate washer
  • qPCR (QuantStudio™ 7 Flex Real Time PCR System)
  • PCR Thermal Cycler
  • Waston LIMS™ for Seamless link to plate readers

Turnaround Time

  • Method development: 1 week
  • Method validation: < 14 days (according to U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) guidance)
  • Sample analysis: <5 days for less than 200 samples; <14 days for less than 1000 samples