Innovative transplant research depends on the standardized acquisition and processing of well characterized biological samples. In order to optimize the usage of our Integrated Research Support Service (IRSS) for downstream translational research, we developed standardized collection and processing methods that have been implemented across the center to reduce non-relevant variability.

We utilized a single IRB-approved protocol, minimizing regulatory effort. Biological sample collection and processing procedures were standardized and sample collection and storage was centralized in a dedicated Biorepository. Standardization has been validated over a three year period through the use of quality control (QC) methods and functional analysis. A Laboratory Information Management System (LIMS) has provided a method for randomized QC of stored peripheral blood mononuclear cells (PBMC) to track viability and recovery, as determined using the Cellometer® (Nexcelom). We validated the functional capacity of stored PBMCs using flow-cytometric based analyses of cytokine release (ICCS) and proliferation (CSFE) of stimulated cells. Utilizing a REDCap® web-based database, these validated samples tracked within the LIMS are integrated with relevant data from the institutional Clinical Data Warehouse and the transplant specific Organ Transplant Tracking Record (OTTR) to provide an interface for investigators to obtain clinically relevant high-quality specimens.

Over the last four years, this service has supported over 30 clinical trials and collaborative studies (including CTOT, CTOTC, ITN), and has processed over 85,000 biological aliquots. We have provided over 2100 biologically characterized samples to researchers within our center and to our collaborators. Our IRSS similarly serves as a core facility for 12 multicenter studies providing feedback in protocol development for standardized collection and processing methods. Through use of the IRSS, we have been able to confidently provide PBMCs with a higher than 87% recovery and 90% viability, as well as related samples, plasma, serum, urine, RNA and DNA.

The IRSS serves as an exportable model for comprehensive clinical transplant research support. It continues to generate a bank of high quality, well-characterized biological samples enabling researchers to translate research findings to clinical care.

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