When do you need to invest in GMP plasmid and when is research grade ok?
This question is part of the following Ask The Expert session:
Plasmid DNA Production for Cell and Gene Therapy
Job Title: Associate Director, EMEA Segment Development for Cell and Gene Therapy
For the production of viral vectors, it is increasingly likely that the FDA regulations will soon recommend the use of GMP compliant plasmids for clinical batches. Plasmids are a critical material attribute, as it can impact the safety and quality of the final product. Therefore, it is highly recommended to start using GMP compliant plasmids when producing clinical batches (starting from phase 1). In addition, one will be prepared once regulatory bodies adjust the regulation. For process development and pre-clinical batches, research-grade plasmids can be used.
For NA-based vaccines, cancer therapies or gene therapies where the pDNA is injected directly into a human body, GMP grade plasmids are required.