WuXi Biologics
Offering End-to-End Solutions
Mammalian based Vaccine Analytical Testing
WuXi Vaccines operates multiple state-of-the-art, premier quality cGMP drug substance and drug product facilities across four countries for the production of a wide array of vaccines from both mammalian and microbial expression systems. All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.
Analytical Development
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
Testing Capabilities
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 | Biochemical | Compendial | Microbiology | Raw Material | Bioassays |
|---|---|---|---|---|---|
| Titer | Residual HCP | Appearance, Color, Clarity | Sterility | Appearance | Engineered analytical cell line development |
| SEC-HPLC | Residual DNA | pH, Osmolality | Bioburden | ID (Raman) | Stable reporter cell line generation |
| CEX-HPLC | Residual Protein A | Endotoxin | pH | Receptor-expressing assay cell lines | |
| RP-HPLC | Protein Concentration: SoloVPE, BCA, MicroBCA, Lowry | Extractable Volume | CCIT | Loss on Dry (LOD) | Cell substrate characterization |
| HIC-HPLC | Western Blot | Moisture Content | Isolates identification | ID (FTIR) | Cell bank qualification and characterization |
| PS 20/80 | SDS-PAGE (NR and R) | Visible Particle | Melting point | Target selectivity assays | |
| Sialic acid assay | Sub-visible Particles | Density | Target-binding ELISA | ||
| N-Glycan profiling | Viscosity | Surface Plasmon Resonance (SPR) | |||
| Peptide mapping | Purity (LC/GC) | Bio-Layer Interferometry (BLI) | |||
| Acetic acid residue | Residue on Ignition (ROI) | Cell-based binding assays | |||
| CE-SDS (Reduced and Non-Reduced) | Residual Solvent (GC) | Receptor occupancy assays | |||
| iCIEF | Trace Metal (ICP-MS) | 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 |
Comprehensive and wide-ranging analytical methods are available to assess the vaccine and antibody during developability studies and cell line development, such as:
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 Materials:
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
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