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

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
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