Newsletter | July 30, 2025

07.30.25 -- What The EMA mRNA Guidance Means For The Industry

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Join the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025, taking place 21–22 October in Vienna, Austria! Centered on the theme Shaping the Drug Delivery Ecosystem, this event explores innovation at the intersection of science, technology, sustainability, and patient experience. Expect powerful keynotes, real-world case studies, expert sessions, and a dynamic exhibition showcasing the future of injectable combination products. Make sure to register!

FEATURED EDITORIAL

Enzymatic Ligation: The Next Chapter In siRNA Manufacturing

During my three days at TIDES, I sat through several talks about the industry’s progress toward enzymatic ligation approaches for siRNA manufacturing. In the following article, I’ll share a few of the biggest takeaways I garnered from these different presentations, with a particular focus on the efficiencies the industry hopes such efforts unlock in the long-term. 

What The EMA Guidance Means For mRNA: Progress, Limitations, And Future Directions

Advancing RNA panelists Tiffany Lucas and Ulrike Jägle home in on the EMA’s guidance for mRNA vaccine quality, sharing their initial thoughts on the guidance’s strengths, while also addressing its limitations for those of us who may be working with mRNA in a therapeutic context.

A Flexible Mindset For Bridging Between Cell-Based Assay Groups

Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

INDUSTRY INSIGHTS

FDA Shifts Reshape Drug Development

Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying ways to make processes more sustainable. Learn how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

LC/MS Method For Measurement In Human Plasma

According to the researchers, this plasma-based measurement has the potential to serve as a critical pharmacodynamic biomarker, facilitating the assessment of novel therapeutic approaches.

Benefits Of PCR-Based mRNA Manufacturing Processes

Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.

Process Development Considerations For RNA-LNP Therapeutics

Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

Shaping Therapeutic Development With Cutting-Edge CRISPR Nucleases

Gain an understanding of how an advanced nuclease portfolio is designed to support CRISPR-based cell and gene therapy development, providing scientists with the best solutions for therapeutic success.

Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.