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Discovery Bioanalysis

Supporting Your Drug Discovery and Non-GLP Bioanalysis

WuXi AppTec’s Discovery non-GLP bioanalytical services support your therapeutic candidates with in vitro ADME, discovery biology, PK, PD and discovery toxicology. Using high-throughput technology platforms that provide high-quality data, our team of experts can provide unique insights that rapidly advance discovery efforts for:

 

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

Small Molecule Development

We offer extensive platform suites available for small molecule bioanalysis, comprised of industry-leading instrumentation to support global studies with rapid, precise and reproducible results. 

Our capabilities include:

Instrumentation

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

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, including an existing library of validated methods and state-of-the-art instrumentation, our experienced non-GLP bioanalytical team can rapidly develop and validate methods to support the development of your new biologics. Our capabilities include:

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, 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