by Alan Hardwick, PhD, David McMillen, Jennifer Martinez, Amanda Austin, Aaron Posey, Connie Ave-Teel, Phillip Maples, PhD, and Susanne Schneider, PhD
Volume 2, Issue 4 (July/August 2003)
A clinical-scale manufacturing process has been developed for the ex vivo expansion of autologous cytolytic T lymphocytes (CTLs) directed against cells infected with the hepatitis B virus (HBV). The process is based on the Rapid Expansion Method (REM) technology originally developed at the Fred Hutchinson Cancer Research Center in Seattle, WA by Greenberg and Riddell. Preparations are underway to initiate a company-sponsored Phase I clinical trial in which REM will be used to expand rare autologous HBV-specific CTLs that will then be infused to patients chronically infected with HBV. Earlier studies have shown that such patients mount only a weak CTL response to HBV. Chronic hepatitis B can lead to severe liver damage such as cirrhosis and hepatocellular carcinoma. By infusing clinical-scale quantities of autologous HBV-specific CTLs into chronic HBV patients, it may be possible to boost the immune system so that it can control the viral infection…
Citation:
Hardwick A, McMillen D, Martinez J, Austin A, Posey A, Ave-Teel C, Maples P, Schneider S. Clinical-Scale Production of Antigen-Specific T Cells Directed Against Hepatitis B Virus. BioProcess J, 2003; 2(4): 27-31.