Vaccines

•   Identify by capillary electrophoresis SDS or IEX, high resolution liquid chromatography mass spectrometry, SDS-PAGE, immunoassay-based methods (ELISA and Western Blot)
•    Protein Purity: orthogonal separation science methods including liquid chromatography and CE-SDS or IEX, high resolution liquid chromatography mass spectrometry with on-line UV detector, SDS-PAGE
•    Empty: Full measurements by ion exchange chromatography and capillary electrophoresis
•    Host cell proteins: ELISA
•    Host cell DNA: qPCR
•    Residual plasmid: qPCR
•    Residual transfection reagents: HPLC
•    DNA sizing by gel electrophoresis or CE-SDS
•    Aggregation: size exclusion chromatography, dynamic light scattering
•    Residual affinity ligands: ELISA
•    Physical titre by ELISA
•    Genomic titre against a standard material by qPCR or ddPCR 
•    Infectious titre by cell-based assays
•    Infection dynamic studies via cell-based assays with multiple endpoints (e.g qPCR, ddPCR and ELISA)
•    Visible and subvisible particles
•    Pharmacopeia tests including appearance, pH, sub visible particles, osmolality

•    Comparability
•    Method development & validation
•    Molecular weight or size
•    Protein or peptide sequencing
•    Post translational modification (PTM)
•    Disulfide-mapping
•    Forced degradation studies
•    Immunochemical properties by ELISA or western blot
•    Glycosylation analysis
•    Amino acid composition
•    Aggregation studies
•    Bioassay for potency

Lipid identity and purity by liquid chromatography mass spectrometry, gas chromatography mass spectrometry and flame ionisation detection (FID), liquid chromatography coupled with evaporative light scattering detection

•    Particle size and charge by Zetasizer, DLS
•    Lipid content: liquid chromatography evaporative light scattering detection
•    Encapsulation efficiency by ribogreen
•    Potency by cell-based assays

DNA Template: 
•    Concentration by qPCR 
•    Residual Host cell proteins by ELISA
•    Residual Host cell DNA by qPCR 
•    Endotoxins

Drug Substance:
•    Identity by RT-PCR. NGS, Sanger and LC-MSMS also available 
•    Concentration: ribogreen
•    Integrity: Agarose gel electrophoresis, capillary electrophoresis, chromatography