MANUFACTURING ARTICLES

• Protecting The Platform: Trade Secret Protection For RNA Biotech Companies

  As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.

• Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity

  Krieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.

• Is mRNA Manufacturing Overbuilt?

  mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

• What Oligo Manufacturing Risks Are We Underestimating?

  Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos. 

• RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation

  From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance. 

• What Baby KJ Taught Us About mRNA COGS

  Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”