The Human Gene Therapy Applications Laboratory (HGTAL)

The Human Gene Therapy Applications Laboratory (HGTAL) at the University of Pittsburgh began in 1992 as an initiative to develop a laboratory where gene therapy vectors could be produced and used in clinical trials according to FDA requirements. With the development of new research programs on gene therapy and the emergence of clinically targeted gene therapy activities at the University, the creation of such a core production facility to manufacture and utilize these materials was critical. The objective of the HGTAL is to produce and use gene transfer systems including but not limited to, replication defective retroviruses, adenoviruses, adeno-associated viruses, herpes viruses and other developing viral vectors for the delivery of genes to human cells in approved clinical trials of gene therapy. In addition to the manufacture of these gene transfer systems, the HGTAL provides guidance to principal investigators on the necessary steps required to use their methods in a way which protects the safety of research subjects according to the guidance provided by the FDA. The HGTAL provides instruction and assistance to the investigators concerning required safety testing, lot release criterion, and the development of appropriate validatable assays and processes for their specific transfer systems.