Newsletter | November 19, 2025

11.19.25 -- The Make-Or-Break Quality Attributes Of Plasmid DNA

SPONSOR

Webinar: Addressing the Challenges of LNP Upscaling: A Reynolds Number-Driven Approach via Junction Mixing Technologies

Scaling lipid nanoparticle (LNP) formulations from lab to GMP production introduces challenges in uniformity and reproducibility. This webinar explores how KNAUER’s Impingement Jets Mixing (IJM) technology provides scalable, physics-based control through constant flow conditions. Learn how fluid dynamics inform LNP quality, enabling safe, efficient, and reproducible RNA therapeutic production from R&D to global manufacturing. Click here to learn more.

FEATURED EDITORIAL

Tackling Challenges In RNA Stability And Organ Targeting

RNA therapeutics are reshaping medicine, but instability and limited organ targeting still pose challenges. Discover how next-gen lipid nanoparticles and smart delivery systems are advancing RNA precision.

The Make-Or-Break Quality Attributes Of Plasmid DNA

We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA. 

Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads

Part one of a two-part series on FDA Commissioner Martin Makary, M.D.'s comments at the Gailen Forum in New York City on October 30, 2025.

INDUSTRY INSIGHTS

What Is The Role Of CROs In Drug Development?

Learn more about how CROs are not just facilitators but strategic innovators essential for delivering new therapies to patients efficiently and safely.

Large Scale Purification Of Oligonucleotides With IEX

As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.

The Current And Future Value Of mRNA Vaccines And Therapeutics

Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and how it is advancing mRNA drug development.

Establishing Analytical Methods For Emerging mRNA-Based Therapies

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

Five Essentials For Accurate Oligonucleotide Chemistry

Uncover five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.

Increasing Batch Size And Reducing Cycle Times For A Biologic

JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

Understanding The Intricacies Of qMSI

Explore quantitative mass spectrometry imaging (QMSI) and leading spatial bioanalysis and biology services that offer one-on-one support throughout your drug development process.

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Webinar: The mRNA Journey: From Design to LNP-Ready Molecules for Research

Discover a validated, end-to-end workflow for producing high-quality IVT mRNA for preclinical research. This Agilent webinar covers every step—from sequence design and PCR-based DNA template preparation to transcription, lipid nanoparticle formulation, and QC testing with Agilent TapeStation and Fragment Analyzer—enabling fast, reliable, small-scale mRNA production for vaccines, protein expression, and gene or cell therapy. Click here to learn more.

SOLUTIONS

Complete Solutions For Every Step Of Pharmaceutical Development

A CRO Accelerating Bioanalysis

Ultra-Sensitive, Precise Structural Measurements Of Your Biomolecules

Services For Aseptic Sampling Solutions

Innovation Delivered With Certainty: Leveraging A Leading Global CMDO

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Webinar: Robust and Cost-Effective mRNA Capping: Critical Quality Attributes and Manufacturing Strategies

Join Roche experts to explore advancements in scalable RNA manufacturing. This webinar highlights the role of capping strategies in ensuring RNA stability and translational efficiency at industrial scales. Attendees will gain insights into adopting new technologies and materials—such as Roche’s GMP Grade Vaccinia Capping Enzymes—and learn best practices for scaling mRNA synthesis from milliliter to liter volumes. Click here to register.