Blood collection, shipping and processing is often the first point of failure for cell based immunology assays, such as ELISpot, flow cytometric phenotyping and functional cell based assays.
When these assays are planned as part of multi-center clinical trials, setting up processes for collecting processing, shipping, preserving blood incorrectly can have catastrophic consequences for the outcome of cell based assay analyses downstream.
Based on our in-depth experience over nearly two decades in working up complex cell based assays in the context of multi-center clinical studies we can help you implement protocols for blood collection, shipping and preservation that give you the best chance for success.
When you plan your clinical study it is imperative that you qualify your blood collection, shipping and processing supply chain for your specific assay read out objective. We can help you design and implement the most appropriate qualification study that can demonstrate that the signal quality from your assay results can match your study objective.
Here are some common failure modes:
The above are just an illustration of possible failure modes. Typically these lead to far less cells being recovered than intended and those cells that are recovered have poor viability and functional performance. Couple this with challenging read out objectives, such as identification of low frequency antigen-specific T cell responses, and the study is designed to fail from the outset.
Planning for workable studies, especially larger ones will automatically require
(i) pre-processed at the collection site, followed by shipping and cetralized cryopreservation at customer generalist CRO sites, follwed by further international dry shipper transfer, or
(ii) shipped directly to ProImmune for processing, cryoperservation and biobanking at ProImmune.
(i) tested at ProImmune’s core laboratories or
(ii) stored and/or forwarded for testing in accordance with the sponsor’s directions