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.”
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.
-
Learn how buffer choice, gradient strategy, and pretreatment steps influence recovery, purity, and resolution when purifying a native RNA oligo, with analytical confirmation and practical guidance.
-
Get a clear view of oligonucleotide development from synthesis to purification and filtration with practical insights to help you streamline workflows and stay ahead in the fight against disease.
-
CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
-
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
-
Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
-
This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.