Vaccines

RSSL offers a comprehensive suite of GMP vaccine testing methods to support you throughout your vaccine development and production.

 

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.

Our analytical capabilities can be divided into the following viral technology categories

  • •   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

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Switchboard: +44 (0)118 918 4000

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