From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing Partnerships

In the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.

A "Hot Take" On mRNA Critical Process Parameters

Bushwacking up a trailless mountain — as many of us may feel we’re doing today with the development of our mRNA therapeutics — is bound to be accompanied by its fair share of drama. These dynamics became increasingly apparent to me as I listened to a presentation unpacking the results of a BioPhorum benchmarking survey on CPPs for plasmid linearization, mRNA drug substance, and mRNA drug product production.

Innovation Advances In mRNA Medicine

The post-pandemic mRNA pipeline surge has led to a substantial investment in innovation. Let’s look at nonamplifying mRNA, saRNA, and circRNA.

A "Hot Take" on Personalized mRNA Medicines

mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.

What Does FDA's Draft Platform Guidance Mean For CGT Companies?

Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.

Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing

Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

Future-Proofing mRNA Drug Manufacturing: The Value of Continuous Improvement

With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.

Methods for mRNA Poly(A) Sizing

This study used Oxford Nanopore Technologies' Direct RNA Sequencing Kit and obtained successful sizing of poly(A) tail regions. The results are presented in a histogram and table format.

Gene Therapy And Oligonucleotide Compendium

Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.

Common Approaches To Bioanalysis Of Oligonucleotides

Weigh an assortment of advantages and disadvantages to determine which strategy is best for a clinical study.

Nucleases - Are They A Problem For NAB Nanosep® Centrifugal Devices?

We examine whether the sample tubes and collection tubes of the NAB Nanosep centrifugal devices contain detectable amounts of DNase or RNase.

Extending The Lower Limits Of Quantification Of A Therapeutic Oligonucleotide Through Microflow LC-MS/MS

Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.

Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma

This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.