Newsletter | July 3, 2024

07.03.24 -- Streamlining Upstream Plasmid DNA Manufacturing


There’s been great progress in establishing platforms for linear mRNA vaccines — but where does this current know-how fall short for those exploring linear and next-gen RNA constructs for non-vaccine products? Secure your spot for Advancing RNA Live’s next digital panel discussion on the current known unknowns (and unknown unknowns) about our mRNA therapeutics candidates that make adopting the traditional QbD approach complicated. Registration is free thanks to the support of Roche Custom Biotech.


CircRNA with Orna Therapeutics' Tom Barnes, & Advancing RNA's ARW

As if Orna Therapeutics' CEO, Thomas Barnes, isn't enough to draw you in to the Business of Biotech, we teamed up with Advancing RNA Editorial & Community Director Anna Rose Welch to co-host this week's episode. Together, Anna Rose and I press Dr. Barnes on his transition from academia to biotech; the therapeutic proposition of circular, or "O", RNA and why it holds great potential to linear RNA constructs; the novel platform- and partnership-based approaches Orna is taking to address B-cell lymphomas and Duchenne Muscular Dystrophy; LNP complexity, and a whole lot more.


Streamlining Upstream Plasmid DNA Manufacturing

Here we will discuss the scalable process workflow solutions available from initial R&D investment to clinical testing and commercialization.

Modeling The Economics Of Vaccine Manufacturing

Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.

Recommendations For Successful IND Approval Of RNA-LNP Drugs

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process of IND filing of novel nanomedicines.

Overcome The Hidden Complexities Of mRNA Process Development

Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.


Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors. Entrust that your program is in hands you can rely on, where integrity is paramount, and excellence is the standard.


Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?

Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

A Snapshot Of The RNA Industry & Its Regulatory Progress

The experts on this Advancing RNA Live panel share their takeaways from several audience poll questions revealing which RNA molecules are getting the lion’s share of attention/development today.