Commercializing Genetically Engineered Cloned Cattle

The past 25 years or more have witnessed many new technological developments in the production of genetically engineered (GE) animals, including cattle. These new technologies include producing GE animals by somatic cell cloning, zinc finger nuclease (ZFN)- and transcription activator-like effector nuclease (TALEN)-mediated genome engineering, and extensive genetic modification by sequential gene targeting. Using GE animals to address unmet medical needs, such as producing large quantities of fully human therapeutic antibodies in a transchromosomic (Tc) bovine system, has become a reality. There is great potential in using GE animals for biomedical applications. However, while tremendous breakthroughs and technological innovations continue, maneuvering through highly innovative research and development into regulatory approval and commercialization of valuable animal biotechnology products that are needed and wanted by consumers, physicians, and patients is challenging. Many complicated, rigorous, and often expensive steps are required, which should be considered during early stages of developing applications in GE animals. These steps include the sourcing of animals and animal-derived material; detailed documentation of gene targeting constructs; cell banking; founder animal establishment and genetic characterization; animal facilities; product collection and processing facilities; and regulatory compliance, risk management, gap analysis, quality assurance, and quality control. Recent success in biomedical applications using GE animals is evidenced by the approval of the first GE animal derived biotherapeutic by the European Union and the United States. However, compared to the rapid advances in technology development, the successful commercialization of products produced from GE animals has been slow. While many products are well into development, scientists considering commercial applications for their research should have a broad understanding of the requirements for the development and commercialization of GE animals and products thereof. For example, it is important to consider the risk of genetic modification to the animal versus acceptance by the public based on the benefits of the application