There are now recommendations in the EU that traceability records should be kept for 30 years for advanced therapies (compared to five years for conventional pharma products). One question that arises is—what happens to this kind of data when a company folds?
Encouraged by bioProcessUK, companies are now reviewing cell-therapy questions, although, in reality, many of these products will not come on the market for some time. However, there are other uses for cells coming up in the near term—particularly in the area of drug testing.
Nathan Griffiths, Ph.D., CSO of Abcellute, described his company’s approach to the preservation of hepatocytes—a cell type vital in drug discovery and development. “Researchers want to know what the drug is doing to you, and what you are doing to the drug,” he said.
Screens of drugs on liver cells or preparations are a good way of testing this and there are a range of options from primary hepatocytes to S9 and microsomes. But the simpler or less physiological the testing material, the less relevance it has to the in vivo situation in man. Primary hepatocytes give the most information in drug testing, but they are hard to obtain and work with. The key enzymes in hepatocytes for screening belong to the CYP group.
Dr. Griffiths noted that CYP enzymes start to “crash” in culture, rendering data from hepatocytes unreliable. “Of course, cryopreservation has been tried, but it has its limitations.”
The Abcellute approach is an alternative method for preserving hepatocytes. The company’s goal is to maximize the use of hepatocytes with its plate-based technology that preserves the viability and function of the cells with a proprietary gel.
“The cells can be reactivated after seven days, and they still have CYP activity and the ability to attach,” Dr. Griffiths explained. The cells have recently been evaluated successfully by third parties against freshly isolated cells, with measurement of CYP activities, he added.
Abcellute hepatocytes also allow for a decrease in the number of animals used in testing, Dr. Griffiths noted. The technology allows hepatocytes, including valuable fresh human ones, to be distributed to a wide number of users, spread across a number of geographical separate sites.
Abcellute has been able to show that the technology can also be applied to tissues, and it is working with Biopta on preservation of human artery tissue. Technologies such as these may be applied to the extension of shelf life of cell therapies in the future and, if successful, will help to improve the economics of these treatments.
bioProcessUK intends to continue to foster dialogue regarding best practices in advanced therapies. Future topics to focus on could include scale-up versus scale-out in manufacturing, discussions with regulators, and the development of an attractive business model for these products to make them attractive to investors.