TOPRA – Navigating the regulatory challenges of plasmid DNA and synthetic DNA as starting materials for mRNA vaccines
Addressing the regulatory challenges of plasmid DNA. While the efforts of the scientific community continue to respond to the pandemic, regulatory guidelines are evolving to support the development of lifesaving medicines. Synthetic mRNA vaccines are the first in a class of products developed and approved for emergency use, at accelerated timelines. However, the scalability and speed of availability of mRNA vaccines are noted to be primarily reliant on the supply of key material – plasmid DNA. More products/platforms are emerging (eg, AAV, lentivirus and DNA vaccines) utilising plasmid DNA or synthetic DNA for various applications. The current position of the EU and US regulatory guidance on plasmid DNA is discussed in this article, along with some suggested considerations.
This article, published in TOPRA (The Organisation for Professionals in Regulatory Affairs), was authored by Satish Muchakayala, Director of Regulatory Affairs, with contribution from Jill Makin, Chief Technology Officer; Jonathan Extance, VP CMC; Cheryl Wilding, Head of Quality; all at Touchlight, UK.
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Touchlight is a privately-owned biotechnology company based in London, U.K., focussed on the discovery and development of DNA-based genetic medicines, including DNA vaccines and gene therapies. Touchlight has developed a novel, synthetic DNA vector known as “doggybone DNA” or dbDNA™.
Touchlight provides doggybone DNA (dbDNA™) research and development services to US partners/customers, alongside the rest of the world.