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Critical Quality Attributes for supply of clinical plasmids for cell and gene therapy development
Webinar On Demand
Plasmid DNA is a critical raw material for establishing the genetic basis for cell & gene therapy medicines. Evolving regulatory guidelines are shifting the definition of quality for raw materials like plasmid DNA as well as promoting earlier use of GMP-grade raw material for cell and gene therapies.
Watch this on-demand webinar where we discuss:
- Why plasmid quality is critical to patient safety
- Shifting regulatory guidance suggesting earlier use of GMP-grade raw material
- Impact to program timeline and cost when transitioning from RUO to GMP-grade raw materials for scale-up and manufacturing
Patrick Thiaville, PhD
Sr Staff Scientist, Research and Development
Patheon Pharma Services
Dr. Thiaville brings more than 20 years of experience in molecular biology and bacterial genetics to his role as Sr Staff Scientist of microbial manufacturing services for Patheon Pharma Services. He was awarded the prestigious Chateaubriand Fellowship from the French Embassy to United States where his graduate work focused on molecular genetics, genomics, and comparative genomics. Dr. Thiaville’s work in genetics lead to dual-doctorate degrees from the University of Florida and the University of Paris-Sud. Since joining Thermo Fisher Scientific, he has worked on design, scale up, and manufacturing of advanced therapeutics to serve patients in need. His passion remains focused on developing transformative new technologies to contribute to patient outcomes and make the world healthier.