Newsletter | February 26, 2025

02.26.25 -- IP Considerations For Early-Stage mRNA Therapeutics Development

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FEATURED EDITORIAL

IP Considerations For Early-Stage mRNA Therapeutics Development

Fortunately, navigating the patent landscape is hardly a “doomsday” scenario. Here, Rothwell Figg partner Dan Shores shares several strategies companies may choose to employ when facing a legal gray area to protect their products from patent litigation upon commercialization.

Matching CDMO Capabilities To Your mRNA-LNP Development Stage

There are many different criteria for selecting a CDMO for your mRNA products. Arcturus’ Qian Ruan explains that a product’s stage of development and the specific needs inherent to that phase of development should be an important guide for companies today, especially given the expansion of the outsourcing sector and the wide range of capabilities.

RNA Sandbox with Johns Hopkins RNA Innovation Center's Jeff Coller & Michelle Kim

In close partnership with Johns Hopkins and TriLink BioTechnologies, Jeff Coller, Ph.D. and Michelle Kim, Ph.D. have built a sandbox for RNA developers and aspirational RNA business builders to play in. On this week's episode of the Business of Biotech, we team up once again with Advancing RNA's Anna Rose Welch to learn about the venture, dubbed the Johns Hopkins University RNA Innovation Center.

INDUSTRY INSIGHTS

Overcome The Hidden Complexities Of mRNA Process Development

Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

Solvent-Free Purification Of D84-mer Oligonucleotide

Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins that enables scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.

Enabling GMP Production Of sgRNA For CRISPR-Based Therapies

Explore critical steps and key regulatory requirements for developing CRISPR therapeutics and gain practical advice on how to avoid common pitfalls.

Assigning IR Absorption Bands For RNA Building Blocks Using MMS

Microfluidic modulation spectroscopy (MMS) can be used to identify RNA base signatures. This study analyzes vibrational modes of A, G, C, and U, revealing insights into electronic environments and molecular interactions.

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.

Nanoparticle Engineering Addresses Aqueous Solubility Challenges

Nanoform

As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.