CELL & GENE COLLABORATIVE BLOG

Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity
In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.
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What Fly-fishing Can Teach Us About mRNA Immunogenicity
In part one of this two-part article, I spell out some of the decisions fly-fishermen must make to “trick” a fish, and how these decisions are akin to those of the mRNA industry as we strive to successfully navigate “the enigmatic beast” that is the human immune system.
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Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply...
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Moderna’s Global mRNA Manufacturing Strategy: A Closer Look
In part 2 of this 3-part series, I argue Moderna’s strategy for scaling its mRNA vaccine manufacturing paradigm globally is one of the best examples the ATMP space has today of what it means to begin with and keep the end in mind.
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Beyond Moderna’s Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm”
It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.
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Moderna’s Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance
We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.
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Cell & Gene Therapy COGS: Words Of Wisdom To ‘Keep The End In Mind’
As a delightfully diverse space, it goes without saying that understanding a product’s process and COGS drivers will be a highly individualized and complex undertaking. However, there were a few valuable points that came up in my conversation with Dark Horse Consulting's Katy Spink that were worthy of sharing as we step back and consider what "keeping the end in mind" will look like for our development paradigm and its...
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Cell & Gene Therapy COGS: Progress & Pitfalls In Our Quest For Affordability
We regularly talk about “getting to know” our products. This can mean a lot of different things depending on the functional area in which we work. But as conversations about affordability and commercial sustainability increase pressure on manufacturing teams, I wanted to get Spink’s thoughts on how we can understand our products from a COGS standpoint and how this will continue to challenge us in the years ahead.
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Cell & Gene Manufacturing Risk Vs. Benefit: How It’s Reflected In Our FDA Interactions
Though many important topics of conversation were broached during the 2022 FDA CMC townhalls, there were two within which the industry is working to define how much is too much or not yet enough. In the following two parts of this article, I’ll briefly unpack some of the high-level best practices offered by the FDA to help you work your way towards “just right.”
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GMP Principles: The True Star Of Cell & Gene FDA Interactions
The questions posed to the FDA during both the cell and gene town halls indicate that we are trying to better define “phase appropriate” development and understand where our material/vendor selection and qualification need to be more diligent. Despite the murkiness of this topic in general, there were a few best practices I took away from the FDA’s recommendations.
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