Quality Considerations for Plasmid DNA as a Starting Material for Cell and Gene Therapies (On-Demand)


Course Description:
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.

Who should participate:

  • 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

The live version of this recording took place on June 21, 2023
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.


Rebecca C. Potts

Senior Scientist II, Global Biologics
United States Pharmacopeia (MD, USA)

Lawrence Thompson
Associate Research Fellow
Pfizer (NY, USA)