Quality considerations for plasmid DNA as a starting material for cell and gene therapies
There is a need for more guidance regarding plasmid DNA used in the manufacturing of cell and gene therapy processes, including the production of mRNA. Recognizing this gap, United States Pharmacopeia (USP; MD, USA) has developed a general chapter to define plasmid DNA best practices.
This webinar will focus on plasmid DNA as a starting material for use in downstream manufacturing operations, comprising topics such as sourcing and manufacture, plasmid quality and testing, risk management, and residual impurities.
This webinar was recorded on 21 June 2023.
What will you learn?
- Considerations for manufacturing
- Quality management tips
- Tips for ensuring DNA starting material quality
- How to conduct risk management
Who may this interest?
- Lab personnel in research and development, manufacturing and production
- Scientists and managers of manufacturing and contract research organizations
- Quality assurance and quality control specialists and auditors
- Regulatory professionals
Speakers
Rebecca C. Potts
Senior Scientist II, Global Biologics
United States Pharmacopeia (MD, USA)
Rebecca Potts is currently a Senior Scientist II in the Global Biologics Department at the USP. Dr. Potts is responsible for the development of compendial standards for cell and gene therapy products, associated reagents, ancillary materials, tissue-based products and proteins. Potts serves as primary documentary scientist to the Plasmid DNA Expert Panel. Before joining USP, Potts was a postdoctoral fellow at National Institutes of Health (MD, USA) and is the author or co-author of several peer-reviewed journal articles. Potts received her PhD in Biochemistry, Cell and Molecular Biology from Johns Hopkins School of Medicine (MD, USA).
Lawrence Thompson
Associate Research Fellow
Pfizer (NY, USA)
Lawrence Thompson is an Associate Research Fellow and Group Leader in Analytical R&D within BioTherapeutic Pharmaceutical Sciences at Pfizer (NY, USA). He is an analytical chemistry, manufacturing and controls Subject Matter Expert for Pfizer’s adenoviral & plasmid DNA-based immunotherapeutics, mRNA drug substances and nucleic acid starting material pipeline (used in rAAV and mRNA production). Prior to joining Pfizer, he worked at a couple of small biotech companies developing serum-based cancer diagnostics. He received his PhD in Biochemistry from Vanderbilt University (TN, USA) and did his post-doctoral work at the University of Tennessee (TN, UAS). His work has generated several peer-reviewed publications and presentations at scientific conferences.
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