title: Challenges associated with the development, manufacturing, and delivery of cellular medicines.
abstract: As the potential of these exciting therapeutics approaches reality, the challenges associated with their discovery, approval, and widespread distribution are just now being realized. The current health care infrastructure is unable to accommodate the complexity of cellular therapy, which exceeds the capability of existing treatment facilities to provide ready access for patients to receive standardized collections for consistent quality of apheresis product and the most consistently acceptable and potent therapeutic agent. The goal is to develop a system for seamless international access to cellular therapies and will involve the unification of the systems for the collection of patient-specific cellular materials, the development of an international network of FDA (and other regulatory agencies) registered facilities, the preservation of patient-specific product control from acquisition to re-infusion, the integration of a sophisticated transportation network to meet the time and environment-critical nature of the raw materials and the finished product, and the development of a comprehensive informatics system to coordinate all of the elements.
authors.affiliation: Progenitor Cell Therapy, LLC, Saddle Brook, NJ 07663, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Preti
mesh_terms: D017690:Cell Transplantation / Q000592:standards*; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic / Q000379:methods; D017277:Drug Approval / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004345:Drug Industry / Q000592:standards; D006801:Humans; D012106:Research / Q000592:standards; D013048:Specimen Handling / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*