Newsletter | March 12, 2025

03.12.25 -- How Are The Costs Of mRNA-LNP Manufacturing Evolving?

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4th In Vivo Cell Engineering & Gene Editing Summit

June 3-5, 2025 | Boston, MA 
Join the 4th In Vivo Cell Engineering & Gene Editing Summit, the premier event advancing in vivo cell and gene therapies from research to clinic. Gain exclusive insights into IND-enabling data, regulatory pathways, next-gen delivery, and breakthrough innovations. Hear from leaders like Capstan, Editas, AbbVie & more to stay ahead in oncology, genetic, and rare disease therapies. Learn more.

FEATURED EDITORIAL

Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation

Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.

How Are The Costs Of mRNA-LNP Manufacturing Evolving?

Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

INDUSTRY INSIGHTS

Co-Precipitation Of Metal Carbonate Templated Protein Microparticles

Learn about the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.

Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

Ophthalmic Drug Delivery

Examine the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

Triple-Negative Breast Cancer: Global Clinical Trial Landscape

With over 1,500 TNBC-focused clinical trials since 2019, research efforts into Triple-negative breast cancer (TNBC) treatments are accelerating despite challenges such as drug resistance.

Optimized Performance Model For Yield And Quality Of The mRNA Product

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.

How Outsourcing RNA-LNP Production Can Have A Competitive Advantage

Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.

Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics

Discover new innovative solutions for mRNA analysis that enhance accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your R&D processes.

Novel Plasmid DNA-Encoded Poly(A) Tails For mRNA Synthesis

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

How mRNA Manufacturers Disrupt The Industry

Learn how biopharmaceutical companies can apply proven strategies to overcome hidden complexities in mRNA production, and discover solutions that can help you rapidly design and build a SU facility.