Discussing Key Challenges with Plasmid DNA: Top 3 Takeaways from an Interactive Roundtable
“What should manufacturers be looking at, what are the requirements and what should we be looking at in the future?” This week, four expert panellists participated in an interactive roundtable to discuss key issues and decision points when sourcing plasmid DNA. Here, I briefly summarise my top three key takeaways from the discussion.
The regenerative medicine industry is growing, pushing developers to refine plasmid DNA manufacturing processes to meet regulatory requirements, while keeping costs down and addressing bottlenecks imposed by the COVID-19 pandemic.
In a recent online panel discussion, hosted in partnership with Akron Biotech, the panellists addressed quality by design in plasmid DNA manufacturing, sharing lessons learned from a commercial perspective.
For this blog post, I consider my top three key takeaways from the discussion, highlighting insights from David Smith (President & Chief Commercial Officer at Akron Biotech), Ricardo Jimenez (VP of Technical Operations at Neurogene Inc.), Sebastian Almeida (Director of Manufacturing and CMC Watchat Akron Biotech) and Donald Fink (Master Practice Expert at Dark Horse Consulting).
Link to Webinar: https://vimeo.com/572042696
1 – Purity, Purity, Purity
“A high bar to meet” and “the biggest risk”. Purity and quality control was central to the discussion, as the panellists agreed that cross-contamination presented the highest risk with manufacturing plasmid DNA.
In order to meet high quality standards, the panellists recommended that a facility should be designed for purpose with good quality systems and processes in place, as well as ready to cater for the different needs of each client. Single-use systems that allow for high segregation and control strategies would be ideal in helping to ensure high quality products, as Donald Fink suggested some instances of cross-contamination may not be immediately obvious.
Ultimately, Ricardo Jimenez explained, scientific excellence in a facility is a key factor, as this influences the extent to which high quality products can be produced.
2 – GMP-like vs GMP-full products
The question of GMP-like vs GMP-full products was raised, as the panellists agreed that GMP-like products are often cheaper with good processes in place, but perhaps lack the advantage of bespoke design.
Key advice from Donald Fink at this stage was to consider where you want to end up with your product, what the timeline is going to look like, and to try to have a plan in place rather than making decisions ‘on the fly’. Be sure to consider what your comparability study may look like, as well as how much time and energy may be required to make changes later in development.
3 – When looking at a CMO, make sure you know what you’re looking for
As purity continued as a central theme of importance, a few questions from Moderator, David Smith, related to what the panellists liked to see (or what would raise flags) when looking at a CMO. Aside from checking the relevant documentation and asking questions about key processes, the panellists agreed that there were a few very obvious things to look for.
A key consideration related to the physical surroundings – whether cleaning equipment (or ‘mops and buckets’ as referenced by Ricardo Jimenez) was noticeably left lying around, or if labs appeared cluttered or disorganised. Another element to this would be if open products were left around for ‘easy accessibility’, causing what Donald Fink described as a ‘maze’ to walk or navigate through.
Ultimately, an organised and well-maintained facility is fundamental to ensuring the highest quality products. It was suggested that clutter and untidiness may be an indicator that personnel perhaps don’t care as much about quality than you do…
Finally, I would like to close by thanking David Smith, Ricardo Jimenez, Sebastian Almeida and Donald Fink for sharing their expertise and insights through such a vibrant and enjoyable discussion.
As I have barely scratched the surface of the areas discussed and issues raised, find out more about the ‘key decision points when sourcing plasmid DNA’, with the full discussion – now available on demand.
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