Viral Vaccines

Viral Vaccine Analytical Testing

General QC Capabilities

HPLC AND CE	Titer SEC-HPLC CEX-HPLC RP-HPLC HIC-HPLC PS 20/80 Sialic acid assay N-Glycan profiling 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)

Viral Vaccine Analytical Capabilities:

Infectivity	Engineered analytical cell line development 200+ in vitro cell models of pathogenesis Cell line identity Cell line stability PFA, FFA TCID50, CCID50 RT-qPCR Live-cell cytotoxicity imaging Reporter cell assays for infection or replication
Potency	Antigenicity and target binding: PCR, ELISA, SPR, BLI, homogenous cell-based binding assays Viral neutralization, PRNT Opsonophagocytosis ELISA / FluoroSpot ELISpot / FluoroSpot Polyfunctional T-cell assays Ag-specific T responses Organoid models of IR Engineered APC / T-cell co-cultures Reporter gene potency assays of immune cells Cell signaling and immune regulation Immune biomarker testing
Safety	NGS for genetic sequencing Reversion to virulence Sterility Mycoplasma Adventitious agents Endotoxin & pyrogenicity: LAL, fFC, MAT, PBMC-based assays ADE Original antigenic sin Identity assays: SDS-PAGE, Western / immunoblot, ELISA, qPCR/PCR sequencing, monosaccharide assays Impurity testing: HCP, DNA, process residuals Product degradation pathway analyses: SEC, iCIEF/CEX, DLS, HTRF, qPCR, MS

*: WuXi Vaccines innovative methods

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