Newsletter | June 12, 2024

06.12.24 -- Quick Takes from USP's mRNA Quality Summit

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The Next Generation Of mRNA Products: Implications For Quality Control

Driven by influential regulatory, business, and scientific forces, mRNA has the potential to revolutionize patient treatment over the next decade. Technological advances that will support these patients include novel RNAs, tissue-targeting lipid nanoparticles, non-lipid nanoparticle delivery vehicles, non-needle administration systems, and decentralized manufacturing models. Nevertheless, these solutions will require novel analytical methods to characterize critical quality attributes and confirm products’ safety and efficacy. Learn more.

FEATURED EDITORIAL

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 for mRNA vaccines and therapeutics. Here's a recap of the event.

New Initiative Seeks To Back Up ICH's Harmonization Mission

An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

Where Does The mRNA Vaccine Regulatory Paradigm Fall Short For Therapeutics?

This Advancing RNA panel of experts shares several important questions those striving to make RNA therapeutics will find themselves confronting when collaborating with regulators.

INDUSTRY INSIGHTS

Process Validation: A Critical Step In A Biopharma Product's Lifecycle

Process validation is a critical step in the successful commercialization of a new biopharmaceutical. Learn about the challenges and the importance of applying it throughout the entire product lifecycle.

Accelerated Development: Gene Therapy Vs. Small Molecule

Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

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.

Increase pDNA DSP Productivity With Sample Displacement Chromatography

Here, two distinct polishing processes using monoliths are compared: bind-elute and the more recently developed sample displacement purification.

Introduction To mRNA Manufacturing

The SARS-CoV-2 virus has changed the course of scientific research around mRNA. Learn about mRNA manufacturing, the structure of an mRNA molecule, RNase-free considerations, and more.

SOLUTIONS

GMP mRNA And LNP-mRNA Manufacturing

RNA Therapies