Quality is a core element of our operations at Intravacc. Thus, we have specialist teams to ensure the high quality and stability of our vaccines. Using state-of-the-art analytical techniques, they develop, improve, and validate characterization and quality control tests for vaccine products, intermediates, seed lots, and starting materials.
With state-of-the-art instruments, such as LC-MS, NMR, HPLC and GC systems, biosensor and qPCR instruments at their disposal, our experienced staff develop analytical methods for existing and newly developed vaccines. We perform method development, including GMP-compliant method validation, stability studies, and consistency in production.
We have expertise in biophysical and immunochemical analyses to evaluate the primary protein sequences, chemical modifications, higher-order structures, and stability of antigens, as well as the accessibility of immune-dominant epitopes. The antigens we work with are highly diverse, from purified live-attenuated and inactivated viruses to toxoids, Outer Membrane Vesicles, subunit vaccines, and conjugated antigens.
We carefully characterize the immunological response to a vaccine by examining humoral and cellular responses in samples from pre-clinical experiments. We focus on assays for T cell activation and use virus neutralization tests and serum bactericidal assays to determine neutralizing antibodies.
Every aspect relevant to the efficacy and safety of a vaccine must be meticulously evaluated with fit-for-purpose assays. We develop tests to detect impurities, such as lipopolysaccharides, host cell DNA and proteins, and to assess product yield and the presence of excipients and adjuvants.
Choosing the right assays to determine manufacturing consistency and product parameters are essential to the quality, potency, and safety specifications of a vaccine. Intravacc has a proven track record in establishing validated quality control methods according to ICH guidelines. We provide all aspects of assay development and validation and method transfer. Furthermore, when part of a GMP campaign, the assays can support an IMPD filing.