Use of human PBMCs for clinical biomarker assay development v1.0
Research type
Research Study
Full title
Development of cellular immune assays using peripheral blood mononuclear cells (PBMCs) isolated from blood products procured from NHS blood and transplant (NHSBT)
IRAS ID
341619
Contact name
Ane Ogbe
Contact email
Sponsor organisation
Moderna Biotech Manufacturing UK, Ltd
Duration of Study in the UK
5 years, 2 months, 31 days
Research summary
Circulating immune cells called peripheral blood mononuclear cells (PBMCs) from humans are widely used in immunological research. These cells are easily accessible and can thus serve as surrogates for evaluating immunological landscapes following natural infection, vaccination or administration of therapeutic modalities. In drug development, they are a critical component in the assays that are used for monitoring immune responses, efficacy and safety profile of various therapeutic candidates. These assays have to be designed, developed and qualified in laboratories before deployment on samples from clinical trial participants.
Residual blood from the NHS Blood and Transplant (NHSBT) apheresis process in blood donors can be purchased for non-clinical use as leukocyte cones, buffy coats and other available blood products. This study aims to procure blood products sourced from NHS BT for the development of immunological assay that identify and measure biomarkers of interest. The blood donors give generic consent for research use, the samples received anonymized, and our use of this by-product extends the lifecycle of the donation preventing waste. For our study, these blood products will be processed in-house to isolate PBMCs which will be cryopreserved for use. These cryopreserved PBMCs will facilitate the design and development as well as to quality control a spectrum of immunological assays such as cell-based ligand binding assays (LBAs) and enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT) assays, intracellular cytokine staining (ICS), activation-induced marker (AIM) assays, proliferation assays, cytotoxicity assays, receptor occupancy assays and other assays requiring flow cytometric readout of biomarkers from cells ex vivo or following in vitro stimulation. In addition to use in assay development, these samples will also be used to provide training to staff. This work will run for the next 5 years.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0228
Date of REC Opinion
9 Jul 2024
REC opinion
Favourable Opinion