Intravacc, a leading Contract Development and Manufacturing Organization for vaccines, and Sanquin Diagnostic Services have collaborated to optimize the in vitro Monocyte Activation Test (MAT) for outer membrane vesicle (OMV) vaccines. This new test has the potential to replace the traditional rabbit pyrogen testing (RPT) method for assessing the safety of vaccines. The implementation of the MAT could significantly reduce the use of animals in vaccine safety testing.
Vaccines are essential for protecting public health, but ensuring their safety is crucial. Currently, the RPT is commonly used to demonstrate the safety profile of parenteral vaccine products. However, the MAT assay has proven to be a robust alternative that can determine the reactogenicity of OMV-based vaccines, even during the developmental phase. A specific OMV-based vaccine candidate, Avacc® 3, designed for Bordetella Pertussis, demonstrated a desirable safety profile in terms of systemic reactogenicity when evaluated using both the MAT and RPT.
The findings of this study were published in the peer-reviewed journal Scientific Reports. Dr. Bernard Metz, Director of Product Characterization & Formulation at Intravacc, describes the study as a significant step forward in vaccine safety testing. The MAT offers the potential to enhance the efficiency and ethical standards of vaccine development by providing a feasible alternative to animal testing.
The joint development project between Intravacc and Sanquin Diagnostic Services highlights a pivotal advancement in vaccine safety assessment. The MAT has proven its applicability for assessing reactogenicity levels of pyrogen-containing vaccines at multiple stages of vaccine development and may eventually replace the RPT. This transition to cellular assays can contribute to a significant reduction in the use of animals, which is currently the standard for vaccine safety profiles.
Intravacc’s OMV platform technology plays a crucial role in the development of vaccines. The platform is based on outer membrane vesicles (OMVs) that possess immune-stimulating properties. These OMVs can be designed to carry immunogenic peptides and proteins that stimulate effective adaptive immunity. Intravacc has optimized this platform to induce a more robust immune response and has developed genetic tools to enhance yield, reduce toxicity, and achieve the desired antigenic composition.
Intravacc, located in the Netherlands, is a global CDMO for infectious diseases and therapeutic vaccines. They have extensive experience in vaccine development and optimization, with their know-how and technology used in approximately 30% of childhood disease vaccines. As for Sanquin Diagnostic Services, they collaborate with Sanquin Research to offer diagnostic and bioanalytical CRO services. Their expertise in immune responses and biomarkers supports the development and monitoring of biotherapeutics and vaccines.
In conclusion, the collaboration between Intravacc and Sanquin Diagnostic Services offers a promising alternative to animal testing for vaccine safety. The in vitro Monocyte Activation Test (MAT) demonstrates its potential to replace the traditional rabbit pyrogen test (RPT) for assessing the reactogenicity of OMV-based vaccines. This advancement not only enhances the efficiency of vaccine development but also promotes ethical standards by reducing the use of animals in testing.
– Scientific Reports, Volume 13, 2023. (No URL provided)
– Intravacc: www.intravacc.nl
– Sanquin Diagnostic Services: www.sanquin.nl