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HQ plasmid DNA: a case for phase dependent approaches to manufacturing

Plasmid DNA is a critical starting material in the production of many advanced therapies including viral vectors and RNA vaccines; manufacturing plasmid DNA to support these therapies brings with it both supply chain and regulatory challenges for product developers. As the number of products in development increases, and with more products entering late clinical phase development, product development companies are being required to develop strategies to address these needs from a commercial and regulatory perspective.

This webinar will address the technical challenges around plasmid production, emerging regulatory guidelines, and offer up phase dependent approaches to plasmid supply for product developers, such as HQ (High Quality) plasmid DNA:

  • Plasmid production
    • Process
    • Testing
  • Regulatory requirements
  • Phase dependent approaches
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Tony Hitchcock

Tony Hitchcock

Technical Director, Cobra Biologics, a Charles River Company

Tony Hitchcock has over 35 years of experience in the biotechnology industry and has spent more than 30 years in the production of complex biologics for clinical trials in the EU and US. He has worked in the areas of process development and manufacturing and has wide experience of engineering and process systems. Over the last 20 years, Tony has specialized in the CDMO field and has contributed to the development of over 30 products for clinical trials including plasmid DNA, viral vectors, bacteriophage products, and recombinant proteins from microbial, mammalian, and insect cell sources.

Arsalan Arif
moderator

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.