Newsletter | November 13, 2024

11.13.24 -- Strategies To Address FDA CMC Trends For mRNA Therapies

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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. The promise of mRNA technologies, addressing global health concerns and personalized therapeutics, relies on innovative analytical methods for product characterization and biosafety testing. Read now to learn more.

FEATURED EDITORIAL

Strategies To Address FDA CMC Trends For mRNA Therapies

By Minghua Liu, Ph.D., Eliquent Life Sciences

A CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.

Top Bottlenecks Facing mRNA Supply Chain

In this first segment from Cell & Gene Live, we explore the state of the mRNA therapeutics supply chain and the major bottlenecks that exist today, including non-GMP grade reagents to sourcing DNA.

INDUSTRY INSIGHTS

Downstream Processing's Key Role In RNA-LNP Drug Development

Article | Precision NanoSystems

Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

Overcome The Hidden Complexities Of mRNA Process Development

Webinar | Sartorius

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.

Single-Use Technology For Quality mRNA Manufacturing

Webinar | MilliporeSigma

Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies.

A New Centre For Continuous mRNA Manufacturing

Article | ReciBioPharm

Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.

Empowering A New Era Of Patient-Centric Medicines

Podcast | Nanoform

Discover the challenges pharma companies are facing as they switch focus as well as the actions and technologies companies are implementing to help achieve a brighter future for patients.

Delivering Global Media Manufacturing Consistency

Infographic | Thermo Fisher Scientific

Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.

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RNAi excitement continues to grow with companies like Argonaute RNA and Kate Therapeutics securing funding to advance RNAi candidates and delivery platforms, along with microRNA work being awarded with a Nobel Prize in Medicine, there’s no better time to announce the 6th RNAi-Based Therapeutics Summit! Find out who you could join including Alnylam, Benitec Biopharma, and Eli Lilly when you download the official brochure.