Newsletter | September 10, 2025

09.10.25 -- Translating an Early-Stage mRNA Therapeutic Into The Clinic

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Drug Discovery US 2025: Innovation Takes the Stage in San Diego

Get ready, San Diego! Drug Discovery US 2025 lands this October 2nd - 3rd, bringing world-leading experts in drug product development and delivery to the West Coast’s scientific hub. Dive into presentations, panels, and roundtables—including a featured session on degraders and molecular glues, with case studies on cutting-edge discovery platforms. Cap off the day at our Innovations & Breakthroughs Under the Stars Garden Party. 

FEATURED EDITORIAL

Translating An Early-Stage mRNA Therapeutic Into The Clinic

In the following Q&A, Ethris CMO Thomas Langenickel shares some of his biggest questions and observations about the evolving mRNA therapeutics space that are the most impactful in translating early-stage RNA candidates into the clinic — particularly when that drug product boasts a novel formulation.

AI, Antigen Selection, & Agile Regulation: A Long Road Ahead

Navigating antigen selection for personalized mRNA cancer immunotherapies is a major challenge for industry and regulators. In this clip, CureVac’s Ulrike Jägle articulates why the integration of AI/ML into clinical development presents a significant and ongoing regulatory hurdle.

INDUSTRY INSIGHTS

2025 Global Report For In-Vivo CAR Cell Therapy

Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

Understanding Tech Transfer In Pharmaceutical Contract Manufacturing

Technology transfer is a crucial process in the pharmaceutical industry, ensuring drugs developed in labs can be manufactured consistently at scale.

Probing RNA Base Pairing And Ligand Interactions In Solution With MMS

Discover why Microfluidic Modulation Spectroscopy (MMS) is a novel, label-free, solution-based infrared technique for probing RNA base pairing and ligand interactions.

Talent Crossover: Extend Your Workforce Through Supplier Partnership

Experts at Sartorius discuss the challenges complex molecules present to drug manufacturers today and the vital role suppliers play in fulfilling talent gaps for their customers.

Establishing Analytical Methods For mRNA-Based Therapies

Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.

Downstream Processing's Role In Optimizing RNA-LNP Drug Development

Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

Key Stages In mRNA-Based Therapeutic Development

Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.

New Hope For Neuronal Diseases With PNP-Based Gene Therapy

A new polymer nanoparticle (PNP) system enables targeted delivery of large genetic payloads to neuronal cells, advancing gene therapies for NF1 and other nervous system disorders.

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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!

SOLUTIONS

Capacity Update July 2025: Analytical Services

Nanoparticle Enabled Formulation And Drug Delivery Solutions

Groundbreaking Nanoparticle Processing Technology

mRNA Raw Materials To Scale Up Your Manufacturing

Streamline Your mRNA Purification Steps

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As additional mRNA therapeutics makers progress toward and into the clinic, we're gathering more knowledge about what makes our mRNA products "tick," and how our processes impact the overall quality of our products. Join this expert panel for a timely discussion in the mRNA therapeutics space. Registration is free thanks to the support of Millipore Sigma.