ICH Revises Q1 Guideline, Advancing Stability Testing Standards

In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

"Mirror, Mirror…": Reflections On Reducing mRNA Production COGS

Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.  

Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics

As many of the presentations throughout the two-day USP quality forum revealed, we’re doing what we must to understand the benefits and the limitations of our methods. Yes, this is painstaking and expensive work. But understanding our methods is also one of the critical steps toward a future in which we can rely upon platform analytical procedures and — channeling our inner Britney Spears — say “[Ooo], I did it again!” to the regulatory agencies for each of the subsequent molecules in our pipelines.  

Is The mRNA Payload The Real MVP of Targeted Delivery?

As one delightfully colorful quote from a panel discussion at the AMM Ascent meeting last fall reminds us, there’s a lot more to be explored, discussed, and understood as it relates to the mRNA cargo’s role in targeted delivery. 

The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?"

During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales. 

High-Throughput Characterization Of RNA

How a multi-capillary electrophoresis (CE) system is used to efficiently separate a wide range of RNA-based molecules by size and demonstrates the multiplex capability for RNA characterization.

Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics

Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows including advanced technologies and methodologies to optimize your research and development processes.

Quantification Of Large Oligonucleotides Using High Resolution MS/MS

Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.

RNA: The Next Era In Therapeutic Development

Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

Assigning IR Absorption Bands For RNA Building Blocks Using Microfluidic Modulation Spectroscopy

Explore the power of MMS in identifying RNA base signatures. This study analyzes vibrational modes of A, G, C, and U, revealing insights into electronic environments and molecular interactions.

The Value Of Peptones For Enhancing Biopharmaceutical Productivity

Peptones, versatile media additives derived from various sources, offer numerous benefits for biopharmaceutical production.

Comparing Real-Time And Digital PCR Technologies

Which PCR technologies are the most effective? Compare digital PCR (dPCR) and real-time or quantitative PCR (qPCR) to determine the best choice for your labs.