Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit

The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.

Assessing pDNA Purity For Cell & Gene Therapies

Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.

mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention

mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.

ARW’s ATMP Manufacturing Must-Reads (ST. PATRICK’S DAY EDITION!)

Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

“To Thine Own [mRNA Product] Be True:” Shakespeare’s Guide To RNA GMP Principles

In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

Future-Proofing mRNA Drug Manufacturing: IVT And Supply Chain

Regulatory and technical uncertainty surrounding mRNA necessitates predictive and proactive innovation enabling better manufacturability assessments, more robust in vitro transcription techniques, and improved downstream processing.

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System

CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.

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.

Sequencing Of Synthetic Oligonucleotides And Their Impurities

We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.

Potent Immune Response With Vernal’s LNP-mRNAs

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

Five Essentials For Accurate Oligonucleotide Chemistry

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

CRISPR sgRNA For Successful Gene Editing: Discovery To Clinic

The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.