Vaccines

Whatever the type of antigen, Quality Assistance covers a wide range of analytical technologies needed to support vaccine development, including product characterisation, development and validation of analytical methods, stability studies, batch testing and bioanalysis to support immunogenicity and protection studies.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development
  • Validation of analytical methods as per ICH guidelines
  • Product characterisation
  • Stability studies
  • Batch testing
  • Bioanalysis
  • Immunogenicity and protection studies.
SUMMARY:
Vaccines capabilities
VACCINE COMPONENTS
ANTIGEN (IDENTITY, PURITY, INTEGRITY) Whole Microorganism (Cell or Virus)
Subunit (Polysaccharide, Protein, Modified Toxin, Conjugate Vaccine, Virosome)
Recombinant Protein
Synthetic peptides
Plasmid
Viral Vector
ADJUVANT (e.g. Al, Ca SALTS, MPLA, GLA)  
ANTIMICROBIAL (e.g. THIOMERSAL, 2-PHENOXYETHANOL, BENZETHONIUM CHLORIDE, PHENOL)  
STABILIZERS (e.g. SALTS, AMINO ACIDS, SUGARS, PROTEINS)  
MANUFACTURING RESIDUALS  
STARTING MATERIALS
SEED LOT Bacterial and Viral Seed Lot System
WCB MCB  
IMMUNOGENICITY & PROTECTION
Size and size distribution DLS/A4F-MALLS
PROCESS-RELATED IMPURITIES
Characterisation of Immune Response  
Download the product sheet for more information