Non-GLP Bioanalysis
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.
Complete Services for Small- and Large-Molecule Drugs
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