Newsletter | December 23, 2025

12.23.25 -- Top 10 Of 2025

TOP 10 FROM THE EDITOR

5 Takeaways From The MHRA mRNA Guidance

Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

IP Considerations For Early-Stage mRNA Therapeutics Development

Reclaiming mRNA's Story: How U.S. Policy Upheavals Are Pushing Us To Adapt

Is The mRNA Payload The Real MVP Of Targeted Delivery?

Pictures At An [mRNA]Exhibition: What We Can Learn From Picasso (Pt. 1)

Translating An Early-Stage mRNA Therapeutic Into The Clinic

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

Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing

10.

Britney Spears' Take On Building Platform Analytics for mRNA Therapeutics

TOP 10 GUEST COLUMNS

EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines

By Minghua Liu, Ph.D., Eliquent Life Sciences

A Guide To Designing mRNA Medicines

By Helen Gunter and Timothy Mercer, Australian Institute for Bioengineering and Nanotechnology, The University of Queensland

Can America's Retreat On mRNA Be Europe's Opportunity?

By Ron Lanton III, Esq., Lanton Law PLLC

What Do We (Really) Know About DNA Quality For In Vitro Transcription?

By Philip Probert, CPI

Do We Really Understand Plasmid Quality's Effects On mRNA Production?

By Antony Hitchcock, principal and owner, AGH Bioconsulting, and Philip Probert, Biologics Technology Lead, CPI

Go From Batch To Continuous RNA Purification With mAb Equipment And QBD

A conversation with Zoltán Kis and Adithya Nair, University of Sheffield

CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides

By Kishore Hotha, Ph.D., Dr. Hotha’s Life Sciences LLC

Tales From The Trenches: Developing Potency Assays Outside Big Pharma

By Jeanette Ampudia, biopharma analytical expert

Oligos Step Into The Spotlight: A Growing Force In Genetic Medicine

By Carl Schoellhammer, DeciBio Consulting

10.

Overcoming CMC Challenges In The Development Of Conjugated LNP Platforms For In Vivo CAR-T Therapy

By Sujit Jain, Senior Consultant, Biopharma Manufacturing Sciences and CMC

TOP 10 INDUSTRY INSIGHTS

Establishing Analytical Methods For mRNA-Based Therapies

By MilliporeSigma

mRNA Vaccines And Therapeutics: Current Trends And Perspectives

By Cytiva

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

By RedShiftBio

CQA Assessment Of LNP-Encapsulated IVT mRNA

By Agilent Technologies

The Future Of mRNA: Four Key Focuses For Industry

By Roche CustomBiotech

Unlocking The IP Benefits Of Novel Nucleases In CRISPR Therapies

By Greg Huegerich, Synthego Corporation

The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine

By Battelle

FAQs – RNA Therapies – Global Clinical Trials Landscape

By Novotech

Co-Precipitation Of Metal Carbonate Templated Protein Microparticles

By KNAUER

10.

Intelligent mRNA Manufacturing Through Process Analytical Technologies

By Recipharm Advanced Bio