Newsletter | July 2, 2025

07.02.25 -- A Guide To Designing mRNA Medicines

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Delivery remains RNA therapeutics' biggest hurdle—especially beyond the liver. In this Advancing RNA Live, Anna Rose Welch is joined by experts exploring nonviral, non-LNP delivery solutions pushing the boundaries of coding and noncoding RNA. Hear what makes these novel vehicles promising and learn how companies are tackling the scientific and operational challenges that stand in the way. Don’t miss this deep dive into the future of RNA drug delivery innovation.

FEATURED EDITORIAL

Regulatory Crossroads: Navigating Recent Shifts At The FDA

At the start of the latest Advancing RNA panel discussion, expert Tiffany Lucas outlines the biggest changes happening at the FDA and speculates on how these shifts may impact CBER’s ongoing work in the ATMP/mRNA space.

A Guide To Designing mRNA Medicines

A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.

The Discovery Of Microbes & Implications For Public Health Today

On this week's Business of Biotech, Thomas Levenson, MIT professor and author of So Very Small: How Humans Discovered The Microcosmos, Defeated Germs — And May Still Lose The War Against Infectious Disease talks about what he learned in the writing of So Very Small, how cultural and political forces shape scientific progress, and what it means for drug developers, public health officials, and patients everywhere.

INDUSTRY INSIGHTS

Nanoparticle Engineering Addresses Aqueous Solubility Challenges

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

Establishing Analytical Methods For Emerging mRNA-Based Therapies

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

Solvent-Free Purification Of D84-mer Oligonucleotide

Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins. They enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.

Assigning IR Absorption Bands For RNA Building Blocks Using MMS

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.

Quality Concepts In GMP IVT mRNA Development, Manufacturing, Analytics

Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.

Unlocking The IP Benefits Of Novel Nucleases In CRISPR Therapies

Incorporating novel nucleases into CRISPR therapies enhances intellectual property benefits through improved licensing, strategic protections, and access to new gene targets.

Biopharma Production And Quality Control With Electrophoresis

Discover how Kaneka Eurogentec, a leading provider of custom DNA synthesis and molecular biology services, enhanced their fragment analysis to achieve higher efficiency and accuracy in their workflows.