Non-GLP Bioanalysis

A Dedicated Team 

Whether you are developing a small or large molecule drug, our dedicated bioanalytical team provides a wide range of services including method development, method qualification and sample collection protocol design. Work is conducted to appropriate standards ranging from high throughput research quality, to Good Laboratory Practice (GLP) assays, suitable for discovery and preclinical development.

The bioanalytical team offers optimized project workflows, an exceptional staff training program and robust state-of-the-art technology platforms. These high-quality platforms provide a strong bioanalytical capability to support both small and large molecule development. This includes biomarkers, immunogenicity and pharmacokinetic (PK) studies.

Bioanalysis for Small Molecule Drugs 

Instrumentation

Experience a bioanalytical team that offers one of the most extensive platform suites for small molecule bioanalysis available. It is comprised of industry-leading instrumentation to support global studies with rapid, precise and reproducible results. The extensive suite of platforms are listed below.

  • 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™

Capabilities

We offer comprehensive bioanalytical 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.
  • Extensive experience in quantitative detection of 100+ endogenous biomarkers in support of the treatment of metabolic disorders, cardiovascular disease and Alzheimer’s disease.
  • Well-developed bioanalytical techniques for nucleotide antiviral compounds, providing rapid bioanalytical solutions to world-leading companies in support of successful registrations e.g. hepatitis C.
  • Established analytical capabilities for microsamples such as, volumetric absorptive microsampling (VAM, Mitra®), capillary tube sampling, dry blood spot, dry plasma spot and microdialysis.
  • Extensive peptide quantitative capabilities (> 700 peptides, molecular weight up to 15,000 Da).
  • Bioanalysis of PEG-conjugated drugs, chiral & cis-trans isomers and ocular/skin samples.

Turnaround Time

  • Bioanalytical studies for discovery screening: 24hrs (in vitro samples) and 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)

Bioanalysis for Large Molecule Drugs

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

Validated in-house methods and reagent inventory saves both cost and time.

  • 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 (method validation according to U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) guidance)
  • Sample analysis:
    • <5 days when analyzing less than 200 samples
    • <14 days when analyzing less than 1000 samples