[WEBINAR] What are the Key Decision Points When Sourcing Plasmid DNA?

[WEBINAR] What are the Key Decision Points When Sourcing Plasmid DNA?

How to properly develop your plasmid DNA from research to GMP and find the right manufacturing partner to support those efforts
As the regenerative medicine industry continues to grow, drug developers must develop pDNA manufacturing strategies that can take them from pre-clinical through commercialisation in a thoughtful, cost-effective way that meets and exceeds regulatory requirements. 

However, the rising number of product candidates, their fast progression through clinical trials and recently the COVID-19 pandemic, have created a bottleneck in supply and manufacturing of pDNA, with backlogs often extending over a year.  

In this webinar, we will discuss quality by design in pDNA manufacturing and share lessons learned from the commercial perspective. These insights will explain how to properly develop your plasmid DNA from research to GMP and find the right manufacturing partner to support those efforts.  

The panel discussion will include:
  • The steps for the development of reliable and regulatory compliant pDNA 
  • The metrics used to ensure the proper quality attributes are met 
  • The main factors in pDNA manufacturing that affect the success of cell and gene therapy commercialisation 
  • A phased GMP approach to ensuring adequate pDNA supply from the pre-clinical to clinical phases 
  • Preparing for trends on the horizon in the gene therapy industry 
 
MEET YOUR SPEAKERS
Moderator: David Smith
President & Chief Commercial Officer
Akron Biotech
Ricardo Jimenez
VP of Technical Operations
Neurogene Inc.
Sebastian Almeida
Director of Manufacturing and CMC
Akron Biotech
Donald W. Fink, Ph.D.
Master Practice Expert
Dark Horse Consulting



 
This webinar has been produced in partnership with Akron Biotech.