Newsletter | December 23, 2024

12.23.24 -- Top 10 Of 2024

TOP 10 FROM THE EDITOR

FDA's Platform Guidance Raises Long-Term Questions For mRNA Makers

Are We Actually Living In An mRNA Regulatory "Desert?"

“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA

A "Hot Take" On Personalized mRNA Medicines

“Holy Deliverability, Batman!”: Next-Gen “Heroism” For The mRNA-[X] Space

“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles

Why Nike's "Just Do It!" Is The Wrong Slogan For The RNA Industry

A "Hot Take" On mRNA Critical Process Parameters

Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At Night

10.

The RNA Therapeutics Supply Chain: A Platform of Relationships

TOP 10 GUEST COLUMNS

Comparability Considerations For mRNA Product Development

By Elaine Peters, Genentech

End-To-End mRNA DS And DP Manufacturing Processes

By BioPhorum

Strategies To Address FDA CMC Trends For mRNA Therapies

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

Forum Notebook: Quick Takes From USP's mRNA Virtual Summit

By Sarita K. Acharya, United States Pharmacopeia and Khaled Yamout, consultant

Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing

By Mo Heidaran, Cellx Inc.

Unpacking The Importance Of Lipid Nanoparticle Production Platforms

By Maik Jornitz, BioProcess Resources LLC

Innovation Advances In mRNA Medicine

By Khaled Yamout and Deborah Day Barbara, The Alliance for mRNA Medicines

A Look At siRNA & Market Trends

By Shalini Nagar, Research Nester

Scaling RNA Production From The Lab To The Clinic

A conversation with John Stubenrauch and Sam Deutsch, Nutcracker Therapeutics

10.

Bridge RNAs: Principles, Applications, And Challenges

By Jie Huang, MD, Ph.D., CSTEAM-Biotech

TOP 10 INDUSTRY INSIGHTS

Establishing Analytical Methods For mRNA-Based Therapies

By MilliporeSigma

Ophthalmic Drug Delivery

By Dr. Tamas Solymosi, Nanoform

End-To-End Solutions To Support Your mRNA Therapeutics Workflow

By Thermo Fisher Scientific

Novel Plasmid DNA-Encoded Poly(A) Tails For mRNA Synthesis

By Lauren Hinkel, Noah Prugar, Susannah Chilton, Olivia McPhee, et al., Vernal Biosciences

Defining A Process For Your Unique mRNA

By Sartorius

mRNA Product IVT Process Insights

By Cytiva

Mechanisms Of LNP-Mediated mRNA Delivery

By Michael Nguyen, Ph.D., Helix Biotech

Insights And Strategies For GMP Manufacturing Of RNA-Lipid Nanoparticles

By Precision NanoSystems

A New Centre For Continuous mRNA Manufacturing

By ReciBioPharm

10.

Optimized Performance Model For Yield And Quality Of The mRNA Product

By Roche CustomBiotech