MANUFACTURING ARTICLES

• From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

  In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

• What You Should Know About USP's Bioassay Updates

  The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

• New Group Wants 'Phase-Appropriate' Thinking To Retire

  Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.

• The Case for Process Simplification in mRNA Manufacturing

  Here, I wanted to share a few additional details from Parrella’s presentation about the efforts he and his team at Kernal Biologics made to improve their overall mRNA-LNP COGS. Though he emphasized the amount of opportunity that exists to improve our utilization of costly raw materials/reagents, as he revealed, there are also opportunities for process simplification.

• The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future

  There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.

• Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing

  Overall, there were three main takeaways I gleaned from our conversation that suggest the oligo sector, though more established than its mRNA cousin, is not comfortable with the status quo and is actively trying to grow beyond the limits of its current manufacturing paradigm. Here in part 1, we’ll start with my number one takeaway, which also comes equipped with a bit of history as to how we find ourselves at our current juncture.