In Vitro ADMET Laboratories Announces US Patent on Pooled Cryopreserved Human Hepatocytes for Drug Development Research

United States Patent (US 9,078,430 B2) was granted to In Vitro ADMET Laboratories LLC, Columbia, MD for the preparation of cryopreserved human hepatocytes pooled from multiple individuals. Pooling of hepatocytes minimizes the impact of individual differences. The pooled cryopreserved human hepatocytes can be used for drug metabolism, drug-drug interaction, and drug toxicity evaluation.

US Patent Number 9078430 B2, titled "Cell Preparation Method," was granted to Dr. Albert P. Li, CEO and President of In Vitro ADMET Laboratories, LLC on July 14th, 2015, for his method of pooling and re-cryopreserving human hepatocytes. The process, trademarked QuickRefreeze™, involves thawing cryopreserved human hepatocytes from multiple individual donors and combining them. This creates “pooled” hepatocytes from multiple donors, which are then cryopreserved a second time. 

Pooled cryopreserved human hepatocytes can be used routinely for studying drug metabolism, drug-drug interactions, drug toxicity, and pharmacology with data representing the average of the various donors in the pool, thereby minimizing individual variations. 

Human hepatocytes represent the 'gold standard' for in vitro drug metabolism and toxicology studies and are widely used in the pharmaceutical industry to aid drug development. Pooled multiple donor human hepatocytes furthers the application of human hepatocytes for routine evaluation of human drug properties by minimizing individual differences. The patented technology exemplifies our continuous dedication towards innovating practical and valuable approaches to further the application of cryopreserved human hepatocytes in drug development.

Albert P. Li, Ph. D., President and CEO, In Vitro ADMET Laboratories LLC

IVAL’s cryopreserved animal and human hepatocytes are globally recognized as being of the highest quality.   Dr. Li's QuickRefreeze™ method reduces cellular damage due to cryopreservation, allowing the hepatocytes to be cryopreserved a second time after pooling, while retaining high viability and other cellular functions similar to those measured in the cells before pooling and re-freezing. One major advantage of the novel technology is the retention of the ability of these twice-cryopreserved human hepatocytes to be cultured (plateable), thereby allowing applications that require primary cultured human hepatocytes, such as P450 induction studies and in vitro hepatotoxicity studies. 

Dr. Li is a pioneer in human hepatocyte cryopreservation techniques, which have been instrumental in the adoption of this experimental system in routine drug development researchIVAL offers two pooled cryopreserved human hepatocyte products-- plateable grade and suspension grade-- providing pooled in vitro test systems suitable for a large variety of research applications. These products are used to support preclinical drug development initiatives related to drug metabolism, drug-drug interactions, toxicity assessment, and most recently, drug transporter investigations, which all support better predictions of drug safety and efficacy.