Summary of the Practices, Procedures, and Policies of Triangle Research Laboratories, LLC (TRL) in Isolation of Hepatocytes from Human Liver Tissue (January, 2014)
TRL is a for profit corporation (business license 14989) located at 6 Davis Drive, Research Triangle Park, NC 27709; we lease our own dedicated laboratory and office space within a facility owned by The Hamner Institute.
We receive non-transplanted whole organs from member organizations in the U.S. Organ Procurement Network, which are known as Organ Procurement Organizations (OPOs). The reasons for non-transplantation are varied but typically involve a mismatch of blood type or organ size between the donor organ and potential recipients within a region, damage to the liver during removal (often due to inadequate intact vasculature), or decision by a surgeon to reject an organ which is nonetheless suitable for use in research. In all cases the OPO is the entity which obtains the organ from the hospital and then determines the proper use to make of it. The OPO obtains informed consent from either the donor or more often from the next-of-kin, and such consent explicitly allows for use of the liver for any research purpose. The OPO is responsible for obtaining demographic information about the donor, relevant medical history information, and the serological testing results.
All organs we receive must conform to specifications agreed upon in the contract between TRL and each OPO, which include standards for BMI, donor demographics, tissue quality as determined by the surgeon removing the liver, medication and social history, and ischemic time (<24 hours by receipt at TRL). Our exclusion criteria include embryonic and fetal tissue, and donors with positive HIV, HBV, and/or HCV serologies, we do not accept them. The documentation accompanying each organ includes a copy of the informed consent (with any possible identifying information redacted), serology results, demographic, social, and medical history information , and a numerical donor ID as assigned by the OPO and which is converted into the TRL lot number. The only TRL employee who can access the original OPO donor ID is our Production Manager, but only the OPO can identify the original donor by link with their assigned ID. Chain of custody is maintained by use of overnight courier services with barcode tracking systems, and by handling information maintained at TRL. All livers are prepared for transportation according to well-established SOPs which apply to organs intended for transplant in order to maximize the organ’s viability.
In some cases TRL receives noncancerous (as determined by a surgical pathologist at the treating hospital) resected liver tissue. Our sources for such tissue are hospitals in our geographic region with which we have contracts and which involve essentially the same process as with non-transplanted organs in terms of consent, confidentiality, serology, demographic, medical, and social history, ischemic time, preparation for transportation, and use of courier services.
Upon receipt at TRL we confirm that the proper documentation has been provided and that the tissue meets all requirements before isolating hepatocytes from it. We isolate, culture, and cryopreserve human hepatocytes using procedures developed in part by Dr. Ed LeCluyse, who is now a researcher at The Hamner Institute, and which is detailed in SOPs followed in all cases. Only three people perform such isolations, minimizing operator-operator variability, and in each case we decide on the use of the hepatocytes (cryopreserved or fresh) based on our inventory and customer demands, and our experience in assessing the suitability of each prep for one format or the other. Unused tissue is disposed of through cremation.
Characterization of each lot is performed in accordance with established SOPs and the results, along with gender, ethnicity, age, BMI, smoking, alcohol, and drug history, medications used, serologies (we accept tissue from EBV+ and CMV + donors), and cause-of-death information are contained in a Cryo Characterization Report. All hepatocytes at TRL are stored in -185C vapor phase liquid nitrogen tanks which have 24/7 environmental monitoring alarm systems with back-up power and on which routine maintenance and calibration is performed according to manufacturer specifications. All employees have assigned duties; receive training at TRL that confirms their competence to perform their duties; receive periodic re-training; and each employee’s training history is kept in the employee’s personnel file.
I attest that this information is accurate, current and complete.
Matt Sherman, Executive Director, TRL, LLC