In-vitro development and optimisation of cell-based assays
Research type
Research Study
Full title
In-vitro development and optimisation of cell-based assays for immune monitoring.
IRAS ID
258920
Contact name
Andreia Soares
Contact email
Sponsor organisation
Synexa Life Sciences
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Synexa Life Sciences is a privately held company that offers a comprehensive range of analytical and advisory services to global biopharmaceutical companies. Synexa specialises in custom-designed assays (tests) to characterise immune responses to novel biotherapeutics and most of our work involves developing de-novo assays or optimising existing commercial assays.
In order to develop and optimise our custom assays, we require whole blood samples from healthy adult donors. The assays we develop are predominantly cell-based with a focus on characterising various markers associated with cellular function. We will assess these cellular markers using a number of technologies including, but not limited to, flow cytometry, ELISpot, microfluidic technology and fluorescence microscopy. These complex platforms will help us to evaluate the strengths and limits of our in-house analytical methods.
At times, part of our assay development process requires temporary storage of whole blood or peripheral blood mononuclear cells (PBMCs) in order to establish long term data on the assay. Ethical approval is sought to authorize the storage of tissue samples (blood and PBMC) from adult volunteers until the optimisation of specific assays are completed. The storage of samples offers the advantage of being able to perform multiple optimisation experiments over a longer period of time from a single blood draw thereby maximizing the amount of data generated and minimizing the number of blood draws required.
REC name
South East Scotland REC 02
REC reference
19/SS/0062
Date of REC Opinion
26 Apr 2019
REC opinion
Favourable Opinion