The Mayo Clinic Cancer Center’s Gene and Virus Therapy Shared Resource has worked for the last decade cultivating knowledge and extending expertise to advance ten pre-clinical research projects into human clinical trials. Director, Mark J. Federspiel, Ph.D. explains the roadblocks to these efforts stating, “we end up dealing with a whole variety of issues mainly around manufacturing and the toxicology/pharmacology studies that the Food Drug Administration requires”. The Gene and Virus Therapy Shared Resource has broken down these barriers by continuously working in partnership with the FDA to support the design and production of appropriate protocols and efficacy data as well as toxicological and pharmacological characterization.
This academic lab’s collaborative efforts enable promising concepts for virus-based therapies to come to light by affording the resources to satisfy FDA toxicology and pharmacology requirements for production. The Shared Resources’ Quality Assurance component supports all of this skilled research in biochemistry, molecular biology, cell biology, and virology by streamlining record maintenance and the FDA reporting process. In this video, an operator can be seen loading a sample on the Cellometer Auto T4 to receive fluorescent imaging and analysis, critical to the lab’s standardized protocols for manufacturing.