title: Commercialising genetically engineered animal biomedical products.
abstract: Research over the past two decades has increased the quality and quantity of tools available to produce genetically engineered animals. The number of potentially viable biomedical products from genetically engineered animals is increasing. However, moving from cutting-edge research to development and commercialisation of a biomedical product that is useful and wanted by the public has significant challenges. Even early stage development of genetically engineered animal applications requires consideration of many steps, including quality assurance and quality control, risk management, gap analysis, founder animal establishment, cell banking, sourcing of animals and animal-derived material, animal facilities, product collection facilities and processing facilities. These steps are complicated and expensive. Biomedical applications of genetically engineered animals have had some recent successes and many applications are well into development. As researchers consider applications for their findings, having a realistic understanding of the steps involved in the development and commercialisation of a product, produced in genetically engineered animals, is useful in determining the risk of genetic modification to the animal nu. the potential public benefit of the application.
authors.affiliation: Hematech Inc., 4401 S. Technology Dr., Sioux Falls, SD 57106, USA. esullivan@hematech.com
authors.forename: Eddie J
authors.initials: EJ
authors.lastname: Sullivan
authors.forename: Jerry
authors.initials: J
authors.lastname: Pommer
authors.forename: James M
authors.initials: JM
authors.lastname: Robl
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D018070:Biological Specimen Banks; D020811:Biomedical Technology / Q000379:methods / Q000639:trends; D001702:Biopharmaceutics; D002460:Cell Line; D003132:Commerce; D003264:Containment of Biohazards; D005818:Genetic Engineering; D006799:Housing, Animal; D011786:Quality Control; D012308:Risk Management