Facts in numbers

Vaccine development is one of the most diverse and fastest growing areas in pharmaceuticals and biotechnology. The serious impacts of infectious diseases like Ebola, malaria, HIV, and COVID-19 on world health have continued to make vaccines a focus of substantial social consideration, and new generations are being explored to find cures for diseases with no effective treatments yet available.

Reef Pharma’s deep experience in cell-based assays, immunology, and potency assay development for biologics enables us to effectively collaborate with sponsors on complex bioanalytical assessments for diverse vaccine varieties. Generation 1 vaccines, which are infectious agent-based, still hold a significant position in disease prevention. Our expertise in developing a range of immune-based methods on a broad set of platforms allows us to efficiently develop these assays under GMP regulatory expectations.

The development of Generation 2 and 3 vaccines, which can include recombinant proteins and virus-like particles (VLPs), nucleic acid- or vector-based vaccines, and emerging virus neutralization approaches such as monoclonal antibodies directed at the target virus, have grown significantly owing to their relative control, reduced risk, and targeted effectiveness. These products are often initially developed using animal models and determination of immune response. Industry focus to address the ‘3Rs‘ – replace, reduce, refine – to minimize the use of animal testing has driven their transition to in vitro potency assays which are often met using immune-based methods. In some instances, this method is complemented with an in vivo assay or a cell-based assay. Cell-based assays for these vaccines are typically required to demonstrate mode of action (i.e. particle or protein interaction with a target cell).