Navigating the Regulatory Landscape for Plasmid DNA Production to Enhance Compliance & De-Risk Drug Products

Time: 9:00 am
day: Pre-Conference Workshop Day


In the complex world of pharmaceuticals, understanding the regulatory framework for plasmid DNA production is paramount to ensuring compliance and reducing the risks associated with drug development. This workshop is designed to provide the essential knowledge and strategies required to navigate the regulatory landscape effectively. Gain valuable insights into key regulatory considerations and best practices to bolster compliance and de-risk your modality of choice.

This workshop will address key industry pain points, including:

  • How to navigate the intricacies of plasmid DNA production regulation, such as differences in production facility guidelines, and the definition of GMP in the US and Europe
  • How to navigate the use of non-GMP plasmids in the manufacturing process for cell and gene therapies, and RNA therapeutics
  • The practical approaches and industry-proven methods for ensuring compliance throughout the plasmid DNA production process, from gene and cell therapy to mRNA and DNA vaccines