XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec
Thursday, October 23, 2014

Bioanalytical and Bioassay Services for Novel Biologics, Biosimilars and Biomarkers

XBL offers state-of-the-art instrumentation and facilities combined with scientific expertise to support innovative Biologic and Biosimilar drug development, as well as biomarker assay development. Let XBL assist you with all your bioassay needs.

 

List of Validated/Qualified Methods for Protein and Biochemical Biomarkers at XBL (PDF)

Our Comprehensive Services Include:


Generation and Characterization of Bacterial and Mammalian Cell Lines for Stable Expression/Production of Biologics

  • Plasmid construction, generation of mammalian cell lines
  • Genomic characterization: cDNA sequencing, RFLP, gene copy number determination
  • Mycoplasma testing

Protein Identification Characterization

  • Electrophoresis (1D,2D), Western Blotting
  • Molecular weight determination using LC/MS (with precision of 1 dalton for 30kDa protein)
  • Quantitation: ELISA, LC/MS, Western Blotting
  • Quantitation: Protein/peptide sequence analysis

Gene Expression and Cell/Tissue Based Bioassays

  • Cell proliferation/death, potency, or other customized functional bioassays for Biologics or small molecules (e.g. multi-drug resistance screening in tumor cell lines
  • mRNA induction and determination by Real Time PCR
  • Enzyme activity
  • Cell signaling and protein modification (e.g. phosphorylation) analysis

PK/PD of Biologics

  • Conduct non-clinical PK/PD studies
  • Bioanalytical method development & validation (ELISA/MSD ECL method, LC/MS, mRNA)
  • Clinical and non-clinical sample analysis
  • PD or safety biomarker measurement

In Vivo Distribution of Biologics using Cryo-imaging and Quanitative Whole Body Autoradiography

Immunopotency Evaluation

  • From animal dosing, organ isolation, target cell preparation, to cytokine measurement