Centers Of Excellence

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

Functional Characterization
Stand-alone Bioassay and Biochemical Assay Services
Major Equipment

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