Therapeutic candidates encounter numerous tests and checks on the road to market. Clinicians and researchers need to have an insight into the mechanism of action (MoA) and potential safety concerns that could pose a problem when introduced into patients. This means that different assays must be used at various points on the drug development timeline
– check out the infographic here. Unfortunately, the most suitable assay is not always available off-the-shelf.
Transitioning from an early R&D phase to the regulated space can present some challenges. Thankfully, the team at Sanquin PBS understand these challenges and contexts, and can help ease the path to market.
Some of Sanquin PBS’s custom and flexible assay setups include:
- Whole blood assays – study a drug in the most natural environment possible
- Killing assays – analyze how effective a drug is at provoking immune-mediated cell killing
- Phospho-flow cytometry – to measure the phosphorylation of cells
- Image stream flow cytometry – combining flow cytometry with microscopy
- 3T incorporation assay – analyzes lymphocyte proliferation after stimulation
- ELISA assays – a robust and versatile workhorse with many applications
Sanquin’s access to fresh blood (from a large blood bank) and more than 25 years of experience in a wide range of topics means that custom assays can be easily and quickly created, whatever your needs. As an active member of EIP (European Immunogenicity Platform) and EBF (European Bioanalysis Forum) the experts are involved in discussions on how to optimize assays and what is (and what is not) needed for validation in the different stages of the drug development process.
The research team have devised hundreds of tests. The diversity of techniques available in-house means that Sanquin PBS can select the best fit for the project. For example, if a new assay does not work on a vendor-specific machine the team can troubleshoot and find a solution. These assays are also developed to any required quality level (ISO, ICHm10, GMP, GCLP) through access to fresh samples and the ability to generate top-quality reagents.