Vaccine development follows a strict regulatory pathway, of which safety assessment is a critical component. In addition, study designs and interpreting the subsequent data are also important considerations. The type of studies depends on what type of vaccine you’re developing. Studies can be conducted in accordance to Good Laboratory Practice (GLP) as applicable:

In vitro immune profiling assays for vaccine and adjuvants development

  • Screening peptide/antigen/live viruses
  • In vitro immunogenicity assays
  • Testing of novel adjuvants and antigen delivery vectors

In vivo immunogenicity testing

  • Challenge and protection studies for vaccine and adjuvants
  • Disease-specific infection models – bacterial and viral
  • Efficacy/challenge studies
  • Adjuvant assessment

In vivo potency assays and safety testing

  • EP, USP or JP guidelines.
  • Hormone potency assays, such as FSH, FSH-LH, PMSG, and hCG (EP or USP)
  • Vaccines, including immunopotency, immunogenicity, antisera generation, and challenge studies (bacteria/viruses)

Lot release testing

  • Identity, potency, purity and impurities
  • Physicochemical properties
  • Presentation attributes
  • Microbiology

Immunogenicity and immunopotency assays

In vivo biosafety testing

  • Antibody production assays
  • Inapparent virus/adventitious agent assay
  • Tumorigenicity  testing

Pyrogen testing

  • Endotoxin testing (LAL)
  • Monocyte activation testing (MAT)
  • Rabbit pyrogen test

Stability studies

  • Real-time and accelerated stability testing
  • Forced degradation studies
  • Long-term stability studies

Genetic stability studies

As per ICH Q5B guidelines, cell substrates must be analyzed at two time points (i.e., on the level of the Master Cell Bank and on the level of the End of Production cells) to show their genetic stability i.e. the genetic sequence of an expression construct is stable throughout the production life cycle to ensure the quality and consistency of the product and production process.

Intox has extensive capability to conduct

  • Restriction endonuclease mapping
  • Southern/ Northern blotting
  • Copy number determination by qPCR
  • DNA and RNA sequencing
  • Plasmid sequencing
  • Retention of recombinant construct

Tumorgenicity/oncogenicity testing

  • Xenograft nude mouse models