Newsletter | October 2, 2024

10.02.24 -- FDA's Platform Guidance Raises Questions For mRNA Makers

FEATURED EDITORIAL

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

As I read through the FDA's draft platform designation guidance and listened to various panel discussions the past few months, a handful of additional observations and considerations came to mind that are important to reiterate for the RNA space, particularly as we advance into therapeutics development.

Scaling RNA Production From The Lab To The Clinic

Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

A Double-Edged Sword? Defining "Efficiency" In mRNA Process Development

In this clip from a recent Advancing RNA LIVE event, panelists address a question about where the best opportunities exist upstream and/or downstream to increase mRNA manufacturing efficiencies.

INDUSTRY INSIGHTS

The Heroes Of Vaccine Development: Lipid Nanoparticles

Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.

Modulate mRNA Therapy Effectiveness Using Modified Ribonucleotides

Learn about the problem of immunogenicity of mRNA, modified mRNA via in vitro transcription production, and choosing fit-for-purpose modified ribonucleotides.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

mRNA: Challenges And Strategies Related To The DNA Template Process

Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.

Keys To Successful mRNA Manufacturing

How can PCR-based technology accelerate mRNA development and manufacturing and design principles/critical parameters to enable the rapid development of lipids for RNA formulation?