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Bioassay Characterization

The biological assay (bioassay) is the only in vitro analytical method designed to reflect the clinical effect of a biologic product. It shows relatively higher complexity and requires  expertise for the development, training, transfer, and execution of the method. The objectives of the Bioassay Center of Excellence (CoE) are:

 

  • To lead WuXi Biologics-proprietary technical innovation in the bioassay arena
  • Provide expertise for bioassay development to meet aggressive project timelines and provide in-depth product characterization data
  • Coordination of bioassay development team with QC testing labs for more efficient method transfer
  • Staff training  of bioassay concepts and principles, methods and technical transfer procedures

 

Service Scope:

  • Development of cell-based and binding potency methods to support  clinical and commercial product characterization, lot release and stability programs
  • Execution of the assay qualification life cycle for cell-based and binding potency methods until established as part of a clinical control system
  • Support testing of lot release, in-process, stability and R&D samples
  • Support global regulatory submissions and agency interactions at clinical, NDA/BLA, and post approval phases
  • Transfer, training and trouble-shooting of cell-based assays to QC labs

 


  • Fab Functional Characterization

 

    • Antigen-binding assays (ELISA, SPR, FRET, Alphascreen, etc.)
    • Homogenous cell-based binding assay (ECL, FACS, etc.)
    • Anti-proliferation assays
    • Cellular signal transduction / apoptosis / killing assays
    • Neutralization assays
    • Adhesion assays and migration assays
    • Antigen-specific immune response and its regulation: T-dependent human and murine responses

 

  • Fc Functional Characterization

 

    • FcγR and FcεR binding assays (ELISA, SPR, FRET, Alphascreen, etc.)
    • FcRn binding assays (ELISA, SPR)
    • C1q binding assays
    • Complement dependent cytotoxicity (CDC)
    • Antibody-dependent cell-mediated cytotoxicity (ADCC)

 

  • Enzymatic Activity Assays
  • Specific cell line and reagent development: QC-suitable analytical cell lines and recombinant proteins for bioassays
  • QC-suitable and proprietary cell-based assays for early phase / IND filing
  • Development of 50+ cellular models of diseases
  • Detailed characterization of all facets of oncological, immune regulatory, and anti-viral Mechanism of Action (MoAs )
  • Clinical sample analysis for efficacy, immunogenicity, and safety
  • Humoral and cell-mediated immunogenicity (ADA)  analysis in vitro and in vivo, ADCC, and ADCP studies
  • Biosafety testing using novel biochemical technologies
  • Microplate reader: MD M2e, M5e, Paradigm, PerkinElmer  Envision, MSD SECTOR S600, xCELLigence
  • Automation: Roche Cedex, Beckman ViCELL, Hamilton Microlab STAR, Tecan Freedom EVO 200
  • Cell analyzers: BD FACSCalibur, Essen BioScience IncuCyte
  • PCR   Real-time PCR system: ABI 7500, QuantStudio 7
  • Biosafety cabinet: Labconco A2, Shang Jing BSC-II A2, BSC-1600 II A2
  • Refrigerated centrifuges: Eppendorf AG 5424R, 5810R, Savant SPD2010
  • Biochemical incubator: MMM Friocell 55
  • Refrigerated plate shake: New Brunswick Scientific Innova 40
  • Microplate washer: BioTek ELX405VRS, 405LS
  • Liquid nitrogen tank: Thermo Fisher Scientific 8212, CY509110CN, MVE 816P-2T-190
  • Ultra-low temperature freezer: Thermo Scientific Forma 7000, 7400V, NBS U725
  • CO2 incubator: Thermo Fisher Scientific 3111
  • Heated immersion circulator: Thermo HAAKE A10B
  • Spectrophotometer: Agilent Cary 100 UV-Vis
  • Protein interaction workstation: ForteBio Octet RED