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Globally, a wide range of candidate vaccines are being developed in order to protect against life-threatening diseases in both humans and animals.
RSSL have a broad range of analytical services to support customers with their vaccine technologies journey from R&D to GMP batch release. These capabilities span the breadth of available technologies, including recombinant proteins, vaccines utilizing attenuated or inactivated viruses and mRNA-based vaccines. With a highly experienced, multidisciplinary team of scientists, we can ensure your products and processes meet regulatory requirements.
• 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