title: Infrastructure development for human cell therapy translation.
abstract: The common conception of a drug is that of a chemical with defined medicinal effect. However, cells used as drugs remain critical to patient care. Cell therapy's origins began with the realization that complex tissues such as blood can retain function when transplanted to the patient. More complex transplantation followed, culminating with the understanding that transplantation of some tissues such as bone marrow may act medicinally. Administration of cells with an intended therapeutic effect is a hallmark of cellular therapy. While cells have been used as drugs for decades, testing a specific therapeutic effect of cells has begun clinical testing relatively recently. Lessons learned during the establishment of blood banking (including the importance of quality control, process control, sterility, and product tracking) are key components in the assurance of the safety and potency of cell therapy preparations. As more academic medical centers and private companies move toward exploiting the full potential of cells as drugs, needs arise for the development of the infrastructure necessary to support these investigations. Careful consideration of the design of the structure used to manufacture is important in terms of the significant capital outlay involved and the facility's role in achieving regulatory compliance. This development perspective describes the regulatory environment surrounding the infrastructure support for cell therapy and practical aspects for design consideration with particular focus on those activities associated with early clinical trials.
authors.affiliation: Human Cellular Therapy Laboratory, Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA. Dietz.Allan@mayo.edu
authors.forename: A B
authors.initials: AB
authors.lastname: Dietz
authors.forename: D J
authors.initials: DJ
authors.lastname: Padley
authors.forename: D A
authors.initials: DA
authors.lastname: Gastineau
mesh_terms: D004345:Drug Industry / Q000592:standards / Q000639:trends; D005160:Facility Design and Construction; D006801:Humans; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration