Course Description:
Discover the role of plasmids as starting materials in cell and gene therapies and how to ensure quality with manufacturing standards.
This webinar will explore the importance of plasmid DNA characterization and control strategies to support the quality and safety of therapeutic products.
Plasmids are essential for producing adeno-associated virus (AAV) and other cell and gene therapy products, requiring relevant manufacturing guidelines and standards.
In this webinar, join experts from United States Pharmacopeia (USP) to learn about their efforts in setting manufacturing standards for plasmid DNA, including highlights from the USP General Chapter <1040> Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies. In addition, this session will also discuss new and upcoming USP reference materials for applications like residual plasmid quantification and DNA topology.
Discussion topics:
- Quality considerations for plasmid DNA as a starting material for cell and gene therapies
- USP’s Analytical Reference Materials (ARMs) to detect and quantitate residual plasmid DNA
- USP’s Analytical Reference Materials to assess plasmid topology
Who should participate:
- Analytical scientists
- 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
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker(s)
Anthony Blaszczyk
USP Senior Scientist II