Newsletter | October 16, 2024

10.16.24 -- Shifting Scales: Considerations For Small-Scale mRNA Production

SPONSOR

It’s impossible to attend an event on the future of RNA therapeutics without hearing about the challenges we’re facing with targeted RNA-LNP delivery. In this final Advancing RNA Live discussion of 2024, we sit down with three LNP experts to parse out the current opportunities and unknowns facing the development of next-generation LNPs. Secure your spot today! Registration is free thanks to the support of Helix Biotech.

FEATURED EDITORIAL

Shifting Sands Scales: Considerations For Small-Scale mRNA Production

Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. 

A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services

These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

How Can Sponsors & CDMOs Collaborate On RNA Analytical/Process Development?

Having worked on both the innovator and CDMO sides of the industry, Advancing RNA LIVE panelist Khaled Yamout outlines where he sees the greatest weaknesses in these critical sponsor-CDMO partnerships and offers guidance on how both parties can improve their collaboration and communication.

INDUSTRY INSIGHTS

Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs

This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.

Nanoparticle Engineering Addresses Poor Aqueous Solubility

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.

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

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

Optimized Performance Model For Yield And Quality Of The mRNA Product

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.

Navigating The Regulatory Maze: Fundamentals For Drug Development

Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey. 

SOLUTIONS

Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles