Real-world insights into automated solutions for cell & gene therapy bioprocessing

Gerhard was born in Austria, and attended college and medical school in Vienna. He moved to the US in the late 1980s to run the HIV research laboratory at the University of Maryland at Baltimore. A few years later he accepted a job at the Johns Hopkins University and started the development of clinical stem cell gene therapy for HIV. In 1995 he moved to Los Angeles to accept a position at the University of Southern California, Children’s Hospital Los Angeles (CHLA), where he was involved in the development of clinical grade stem cell gene therapy transduction and cell processing procedures. He performed all cell processing for the clinical trials of stem cell gene therapy for HIV, including the first child in the world treated with stem cell gene therapy for HIV. It was also at CHLA where he started with the development, design and implementation of academic Good Manufacturing Practice (GMP) facilities for cellular therapies.

In 2002 he was recruited to Washington University in St. Louis to build and direct a new GMP facility and center for cellular and gene therapy. The GMP facility there was soon named one of the best academic GMP facilities in the United States at that time, and attracted many visitors from the US and abroad. In 2006 he was recruited back to California, to UC Davis, to be part of the new Stem Cell Program. Here he designed and has since been directing the UC Davis GMP facility, which opened in February of 2010, again being among the best academic GMP facilities in the US. It has gone through FDA review and sign-off, and has also received excellent reviews in the major facilities grant application to the California Institute for Regenerative Medicine (CIRM). CIRM awarded 20 million dollars to UC Davis to build the UC Davis Institute for Regenerative Cures, of which the GMP facility is an integral part. The state of the art setup he created at UC Davis allows moving laboratory research with human stem cells into clinical applications, and is therefore vital in developing cures and treatments for a multitude of currently incurable diseases. Over the last 8 years, several novel manufacturing technologies for gene therapy vectors have also been pioneered in this facility. The UC Davis GMP facility currently manufactures products for six clinical trials conducted in several centers nationwide.