Biomarker in Drug Discovery

Biomarker analysis can be performed at every stage of drug R&D using cell cultures, serum, plasma, urine, tissue extracts, and more. Samples are examined to analyze patterns of biomarkers that correlate with progression of disease or therapy as well as metabolic and toxicity indicators.

WuXi Biology provides integrated biomarker services, including biomarker discovery, gene expression profiling, microRNA detection and profiling, SNP genotyping, signaling and metabolite biomarker profiling. In addition to traditional western-blot and ELISA, our biomarker services utilize a broad range of cutting-edge technologies for both single and multiplex assay platforms, such as qRT-PCR, Meso Scale Discovery (MSD) Multi-Array detection, Flow Cytometry and cytometric bead arrays.

mRNA Real Time qPCR Assay and Array

WuXi Biology has SYBR-Green- and TaqMan-based options for real time qPCR using ABI7300/7500/7900 system, which meets a wide variety of needs of gene expression analysis from clients. Assays are carried out in HTS compatible 96-well or 384-well plate format, providing high reproducibility, specificity, sensitivity, and broad dynamic range. Using ready-to-use commercial or customized PCR arrays would help to better understand biological functions of genes of interest in network, and speed up drug profiling and discovery

SNP Genotyping

WuXi Biology provides SNP genotyping services with high-confidence results using TaqMan genotyping technology. With the largest collection of ready-to use human SNP assays available, TaqMan technology enables us to do almost all sorts of SNP genotyping using either pre-designed or custom human & mouse SNP assays. Upon receipt of the SNP assays and your DNA, the standard TaqMan SNP assay will be run following the protocol as recommended by the manufacturer.

Biomarker assessment using SNP genotyping services, TaqMan

microRNA Detection and Profiling

We also provide fast, easy and accurate microRNA profiling services using Evagreen and TaqMan based real-time qPCR run on the Applied Biosystems 7900HT Fast Real-Time PCR System.

Profiling of hundreds of miRNAs can be completed in wihtin 5 hours. It’s ideal for human, mouse, and rat profiling and requires only minimal sample amounts — as little as 1 ng of total RNA input — making it suitable for FFPE, FACS, biopsy, and other very small samples.

microRNA, miRNA profiling for biomarker support using qPCR, Evagreen, and TaqMan

Biomarker Assay with Flow Cytometry

WuXi Biology provides direct expression and comparison analysis of biomarkers using multi-color fluorescence flow cytometry. We are equipped with dual lasers which allow exploring cell type markers and activation markers in one assay on the single cell level with high sensitivity, minimal compensation and maximum flexibility in fluorochrome selection. Up to four different biomarkers, intracellular markers or cell surface markers can be analyzed in parallel. It’s also equipped with HTS sampler compatible for 96- and 384-well assay format with dramatically increased throughput.

FACS, multi-color fluorescence flow cytometry services to support biomarker discovery, CXCR5, CCR2

Multiplex Biomarker Profiling

Utilizing a state-of-the-art Meso Scale Discovery® Multi-Array® detection unit, we can analyze and quantify a wide range of single and multiplex assays for biomarkers and cell signaling pathways. The detector unit is based on electro-chemiluminescence technology, the assay kits also being provided by MSD. This platform has become the industry standard within many large pharmaceutical companies for supporting in vitro, preclinical and clinical drug discovery and development.

We also own BD FACS Calibur equipped with the high throughput sampler (HTS) option. Cytometric bead array immunoassays run on BD flow cytometer combined with ready-to-use kits and analysis software can get multiple results from a single small-volume sample and avoid artifacts associated with enzyme-dependent signal generation.

MSD SI 6000 and BD Cytometric bead multi-array detection systems enable the detection of biomarkers in single and multiplex formats with exceptional sensitivity, wide dynamic range, convenience and multiple sample matrix options such as cell culture, serum, plasma and CSF, etc. The multiplex assay formats allow the measurement of multiple analytes simultaneously within a single well using a small amount of sample, thus increasing throughput and enabling novel assay formats. The MSD SI6000 instrument accommodates 96-, 384- and 1536-well single-spot plates as well as 24-, 96- and 384-well multi-spot plates. The BD Cytometric bead multi-array accommodates 96- and 384-well plate format.

We offer the vast range of single and multiplex biomarker assay services including but not limited to:

  • Cytokines and Chemokines
  • Cell signaling pathways
  • Metabolic pathways
  • Oncology
  • Toxicology
  • Cardiac, vascular and growth factors
  • Immunogenicity
  • Fertility
  • Hypoxia
  • Bone
  • Bioprocess

Clinical Biomarker Platform

Our Clinical Biomarker platform includes a CAP-certified pathology, a flow cytometry and molecular biology lab with GCP compliance. Our strong team is composed of well-trained immunologists, board-certified pathologists, biomarker experts and qualified technicians.

Platform overview:

  • Pathology lab: Provide biomarker testing in clinical studies, including
    • H&E and histology analysis
    • FFPE sample process and slide cutting
    • IHC/ICC,IF, EHC, TCT, FISH, DISH, RNAscope, multiplex-IF
  • Flow cytometry lab:
    • >40 biomarker/cell markers
    • services covering immune-phenotyping, biomarker analysis, PD/PK for cell therapy, biomarker analysis, receptor occupancy, phospho-biomarker analysis and tumor microenvironment analysis
  • NanoString-based gene expression profiling
    • Gene expression profiling with up to 800 genes in one panel
    • enabling GEP in difficult samples like FFPE
    • panel covering hot genes/pathways/function in immunology/oncology
  • Molecular Lab:
    • qPCR, cMET exon14 skipping and EGFR mutation testing

Biomarker Services list

  • CDx development, sample management
  • Analytical services
  • Histopathology, biomarkers, molecular pathology, digitized pathology, flow cytometry
  • Project Management
  • Project Setup
  • Investigator Support Services,
  • Lab manual, CRA/CRC training
  • Clinical Trial lab materials and Logistics support
  • Contract & Proposals
Clinical biomarker platform including pathology services, NanoString gene expression profiling, histopathology

Lab Management  

  • LIS, LIMS system and reporting system
  • 3Q for newly-installed equipment and PM for In-use equipment
  • Records & Logbook management and archives
  • Equivalence test for replicate instruments
  • Security Monitoring & Privacy Policy
  • Temperature and humidity monitor
  • Short turnaround time

Quality Assurance

  • Internal and external assessment
  • QC and monitoring actions
  • Proficiency Test (2 runs per year)
  • Trained and qualified staffs
  • Project management
  • Data management, transfer and archives
Clinical biomarker lab management, QA/QC, LIMS system, CRA/CRC training, project management