Discovery Bioanalysis

Supporting Your Drug Discovery and Non-GLP Bioanalysis

Discovery non-Good Laboratory Practice (GLP) bioanalytical services support your therapeutic candidates with in vitro ADME, discovery biology, PK, PD and discovery toxicology. Our team of experts and high-throughput technology platforms rapidly advance discovery efforts by delivering unique insights through high-quality data.

  • Small molecule development
  • Large molecule/biologic development
  • Custom Bioreagent Development

Small Molecule Development

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 capability of each platform is 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.

HPLC, 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

Large Molecule Development

Using the latest immunochemical capabilities, WuXi AppTec can rapidly develop and validate methods to support the development of your new biologics. Using an existing library of validated methods and state-of-the-art instrumentation, our experienced non-GLP bioanalytical team has successfully expedited numerous biosimilar projects to completion.

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, TDAR

Instrumentation

  • Flow cytometry (BD FACSCanto™ II, 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

Custom Bioreagent Development

Our bioreagent team develops custom reagents to support your candidates in the assessment of immunogenicity, PK and PD bioanalytical services. Our validated customized reagents rapidly analyze therapeutic candidates and advance development efforts.

Our development team can generate customized antibodies and proteins including:

  • Monoclonal
  • Polyclonal
  • Recombinant proteins
  • Peptides