Newsletter | March 20, 2024

03.20.24 -- Shakespeare's Guide To RNA Therapeutics GMP Principles


The success of nucleic acid modalities and LNP delivery systems relies on robust and consistent processes to make and purify the drug substance and then formulate it to ensure successful delivery to the intended target. A range of analytical techniques is necessary to ensure product quality and patient safety. This white paper provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products. Learn more here.


“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 provided 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. 

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

Once a month, I compile the ATMP articles and industry updates I think are most worthy of your time into an unconventional roundup article. As we recently celebrated St. Patrick's Day, I took my latest inspiration from some traditional Irish drinking songs. Please read responsibly. 

Inhalable mRNA With Ethris' Carsten Rudolph, Ph.D.

Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma. 

How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing

To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

The State Of The Linear mRNA Supply Chain — In Brief

In this clip, Sanofi’s Greg Troiano kickstarts our discussion on some of the advances he’s seen in the supply chain for linear mRNA-LNP products, both in terms of supply availability and supplier capability.

Risk And Supply Chain Continuity Management: Biologics Industry Perspectives

We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. 


Establishing Analytical Methods For Emerging mRNA-Based Therapies

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

LNP Formulation For mRNA Delivery

Microfluidic mixing is one of the most effective means to formulate LNPs because of its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.

Cell & Gene Therapies – Changing The Healthcare Landscape

Experts discuss how cell and gene therapies are changing the healthcare landscape and what needs to be done to bring these advanced therapies to patients.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.