WuXi Vaccines

Microbial Analytical Testing

Our dedicated team of highly-trained and experienced professionals allows us to offer:

Analytical method transfer and qualification
In-process control testing support
GMP DS/DP release and stability studies
QC space comprising bioassay, physicochemistry, compendial testing, biochemistry, and microbiology laboratories as well as reference standard and stability storage rooms.

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, MicoBCA Blot 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	Target selectivity assays Antigen-binding ELISA Competitive ELISA Sandwich ELISA Western blot / Immunoblot SDS-PAGE (Reduced and Non-Reduced) Monosaccharide functional assays Epitope mapping assays Surface Plasmon Resonance (SPR) Bio-Layer Interferometry (BLI) Homogeneous binding assays Receptor-ligand binding assays Antigenicity assays Relative potency assays In vitro immunoreactivity assays Competitive inhibition assays Toxin neutralization assays Cell-based potency assays Receptor binding inhibition assays Agglutination assays