Aldevron Breakthrough Blog

Seeking Faster Paths to the Clinic

Need for speed emphasized at American Biomanufacturing Summit

The American Biomanufacturing Summit, held in San Francisco in April, is a senior-level event attracting over 200 biopharmaceutical executives sharing the latest information from the industry. One top item consistently discussed was how the expectations of speed have been dramatically changed after how quickly COVID-19 vaccines were developed and moved to market, most particularly the mRNA vaccines.

This has changed some thinking on how to leverage this speed into other therapies and modalities, as mRNA and LNPs are now listed as transformative modalities along with cell and gene therapy. From that perspective, it also brings up manufacturing strategies, with many questions for cell therapy being raised about POC manufacturing versus distributed manufacturing versus central manufacturing strategies.

Changes in speed expectations coupled with supply chain issues led to discussions of the benefits of building a robust RNA pipeline, post-COVID manufacturing, C&GT-specific scale-down issues/concerns, and the need to better plan for clinical-to-commercial infrastructure and outsourcing. Several concerns were raised including the implications of the shrinking manufacturing floor and the need to utilize younger generational talent as the digital transformation of manufacturing continues.

It was also apparent from the Summit that FDA guidance for release and commercialization of therapies is a concern as well, especially when it comes to analytics and defining new standards. While draft USP guidelines were recently published for mRNA vaccines, platform technology for mRNA therapeutics is still being developed.

Tied to that, attendees mentioned it’s important to remember that this is not a mature market, especially for RNA. And while developers often don’t have well-characterized platforms, their primary goal is still to file and go commercial first in spite of having sub-optimal platforms. Timeline is everything for some organizations as so many therapies target the same genetic diseases.

Overall, the Summit provided a positive outlook for the future of the industry, with an overarching theme by attendees of looking for partners who can best support them and get them through the clinic fastest.

Rich Latvala

Topics: rna, conferences, FDA