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
In vivo immunogenicity testing
In vivo potency assays and safety testing
Lot release testing
Immunogenicity and immunopotency assays
In vivo biosafety testing
Pyrogen testing
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
Tumorgenicity/oncogenicity testing
