Newsletter | July 23, 2025

07.23.25 -- The Art Of A Successful mRNA IND Submission

FEATURED EDITORIAL

Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward

Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. 

Decoding Regulatory Expectations: The Art Of A Successful IND Submission

Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with their IND. CureVac’s Ulrike Jägle furthers the discussion, offering a critical best practice she and her colleagues rely upon to streamline their regulatory interactions.

7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

INDUSTRY INSIGHTS

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

Reducing Risk In mRNA Therapeutic Development

Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.

What Is Causing Limited Bioavailability

Discover how this label-free whole-body QMSI combined with plasma LC-MS/MS can help identify the root causes of limited bioavailability and guide smarter optimization strategies early in development.

Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier

Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.

Transforming Nanoparticle Processing Through Innovation

Learn about an innovative closed, single-use system and proprietary mixing technology aimed at improving reproducibility and reducing contamination risks in biopharma manufacturing.

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.

SPONSOR

RNA Leaders USA Congress

The RNA Leaders series explores scientific, clinical, and commercial advancements in RNA medicines, including RNAi, antisense, and mRNA therapies. This September, the 4th USA edition returns to the East Coast, welcoming 350+ attendees across oligos, mRNA and next-gen RNA streams. Join biotech leaders, discovery innovators, delivery developers, manufacturers, pharma, and investors at this exclusive forum for senior RNA experts advancing RNA-based therapies.