Newsletter | May 14, 2025

05.14.25 -- Alnylam On Commercializing RNAi Therapies

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Webinar: Turbulent Times: How to successfully control the upscaling of your LNP formulation with KNAUER’s Impingement Jet Mixing

KNAUER’s webinar on Lipid Nano Particles (LNPs) covers fundamentals, formulation challenges, and upscaling strategies. Topics include lipid composition, mixing techniques like IJM, and GMP compliance. Designed for professionals, it offers insights into efficient, scalable LNP production from lab to industrial scale. Click here to learn more.

FEATURED EDITORIAL

Commercializing RNAi Therapies With Alnylam's Tolga Tanguler

On today's episode, Tolga Tanguler, EVP and Chief Commercial Officer at Alnylam Pharmaceuticals, talks about commercializing RNAi therapies, how they fit into health insurance reimbursement systems, the company's use of value-based contracts, and building therapeutic franchise "skyscrapers." 

From Promise To Precision: Defining The Therapeutic Niche for mRNA

By AR Welch, Editorial & Community Director, Advancing RNA

CureVac CEO Alexander Zehnder shares his thoughts/visions on how mRNA neoantigen vaccines could become even more revolutionary for patient populations in the future. 

Improving IVT Processes: Addressing Analytical & PAT Shortcomings

Advancing RNA Live panelists identify what is “as good as we can get right now” in terms of understanding our IVT reactions while sharing their ideas on how we can arrive at a future that includes real-time monitoring of our drug substance production processes.

ICH Revises Q1 Guideline, Advancing Stability Testing Standards

By Md Saddam Nawaz, ACI HealthCare Ltd.

In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

INDUSTRY INSIGHTS

In-Process Control Of pDNA Production On CIMac pDNA Analytical Column

Application Note | Sartorius

Effective plasmid DNA production requires robust in-process monitoring. Here, we demonstrate a purification process incorporating analytical techniques to track product quality and purity.

Harnessing Chemistry For Scalable Manufacture Of Lipids

White Paper | Curia

Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.

Developing A Comprehensive Regulatory Approach For LNP Drugs

Article | Cytiva

The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive, strategic approaches, developers can overcome regulatory hurdles on the path to approval.

The Next Generation Of mRNA Products: Implications For Quality Control

Article | MilliporeSigma

To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.

The Role Of CROs In Drug Development

Q&A | Novotech

In the rapidly evolving landscape of drug development, Contract Research Organizations (CROs) play a pivotal role. Learn more about CROs and selecting the right one to partner with.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

Infographic | ReciBioPharm

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

Targeted LC-MS/MS Detection Of Lipid Impurities In Lipid Nanoparticles

Application Note | KNAUER

Learn about an HPLC-MS/MS method for detecting lipid impurities in lipid nanoparticles (LNPs) and why it is critical for quality control of LNP-based drug delivery systems.

Expand Your Toolbox For Quality mRNA Manufacturing

White Paper | Roche CustomBiotech

Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.

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Join Advancing RNA Live for a dynamic discussion on the latest regulatory guidances from global agencies and what they mean for mRNA vaccine and therapeutic development. Discover key challenges, actionable insights, and best practices to accelerate your programs—no matter your approach. Don’t miss this opportunity to gain expert-driven clarity. Registration is free thanks to the support of Roche CustomBiotech.