Contact Us
菜单
Telephone sharing button Contact Us linkedin sharing button LinkedIn mailbox sharing button wuxivaccines@wuxibiologics.com
arrow_left sharing button
arrow_right sharing button

Mammalian

Analytical Testing

At WuXi Vaccines, our analytical development teams facilitate our one-stop R&D endeavors in collaboration with our other discovery and CMC development laboratories. We offer comprehensive analytical services for a wide variety of vaccines (e.g., VLP and recombinant protein subunit) or prophylactic antibodies.

 

Our extensive testing services support developability studies, in-process analysis, cell line, process development, formulation development, product characterization, lot release, stability studies and IND/BLA/MAA/EUA dossier preparation.
 
Our vast repertoire of analytical techniques provides the full range of methods required for biomolecular analysis. Over 1,000 established methods including compendial, physicochemical, biochemical, biophysical and biological assays (bioassays) supported by our experienced teams are available. From new vaccine and antibody discovery to regulatory filing, we manage a method’s lifecycle from development to qualification and validation and transfer to quality control or other departments and provide investigation and troubleshooting support as needed. Equipped with cutting-edge instrumentation and first-class talent, we provide systematic solutions for integrated projects while catering to special analytical needs in the form of standalone projects.

________________________________________

Comprehensive Analytical Services to Support CMC Development

Whether you require bioassay development, product characterization, routine testing, or other types of analytical testing, our comprehensive services are available as part of an integrated program or standalone.

HPLC AND CE
  • Titer
  • SEC-HPLC
  • CEX-HPLC
  • RP-HPLC
  • HIC-HPLC
  • PS 20/80
  • Sialic acid assay
  • N-Glycan profiling
  • Peptide mapping
  • Acetic acid residue
  • CE-SDS (Reduced and Non-Reduced)
  • iCIEF
Biochemical
  • Residual HCP
  • Residual DNA
  • Residual Protein A
  • Protein Concentration: SoloVPE, BCA, MicoBCA, Lowry
  • Western Blot
  • SDS-PAGE (NR and R)
Compendial
  • Appearance, Color, Clarity
  • pH, Osmolality
  • Extractable Volume
  • Moisture Content
  • Visible Particle
  • Sub-visible Particles
Microbiology
  • Sterility
  • Bioburden
  • Endotoxin
  • CCIT
  • Isolates identification
Raw Material
  • Appearance
  • ID (Raman)
  • pH
  • Loss on Dry (LOD)
  • ID (FTIR)
  • Melting point
  • Density
  • Viscosity
  • Purity (LC/GC)
  • Residue on Ignition (ROI)
  • Residual Solvent (GC)
  • Trace Metal (ICP-MS)
Bioassays
  • Engineered analytical cell line development
  • Stable reporter cell line generation
  • Receptor-expressing assay cell lines
  • Cell substrate characterization
  • Cell bank qualification and characterization
  • Target selectivity assays
  • Target-binding ELISA
  • Surface Plasmon Resonance (SPR)
  • Bio-Layer Interferometry (BLI)
  • Cell-based binding assays
  • Receptor occupancy assays
  • Competitive ligand-binding assays
  • Reporter gene potency assays
  • Cell signaling pathway activation assays
  • Cytopathic effect (CPE)-based assays
  • Cell viability and proliferation assays
  • Apoptosis assays
  • ADCC surrogate assays
Notice:

You are leaving WuXi Biologics Website, after which our Privacy Notice will not apply. Please keep it in mind the protection of your privacy. Are you willing to proceed?

Yes, continue to proceed
No, stay on this Website