Newsletter | April 3, 2024

04.03.24 -- Comparability Considerations For mRNA Product Development

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Bringing 400+ mRNA experts to Boston this July, the 4th mRNA-Based Therapeutics Summit returns to share exclusive scientific and strategic insights spanning the end-to-end of mRNA drug development. Select your sessions from 4 tracks of content dedicated to Discovery, Translation, Clinical Development or CMC, and join the Next Generation mRNA Delivery Day or Regulatory Affairs Strategy Day to maximize your learnings. See the program.

FEATURED EDITORIAL

Comparability Considerations For mRNA Product Development

Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview of this proposed legislation. 

How Could saRNA And circRNA Simplify Manufacturing And Supply Chain Management?

Explore the broad benefits and challenges that could be encountered by working with self-amplifying and circular RNA modalities — particularly in terms of manufacturing, raw material supply, COGS, and patient centricity.

INDUSTRY INSIGHTS

End-To-End Solutions To Support Your mRNA Therapeutics Workflow

Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality, and regulatory needs from development to commercialization.

Plasmid DNA And Advanced Therapies: Accelerating Path To Clinic

Examine the challenges CGT innovators face and how adhering to GMP requirements from an early stage helps ensure successful downstream applications.

Manufacturing Strategies For mRNA Vaccines And Therapeutics

mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of nonviral delivery systems.

End-To-End Cold Chain Management: A Next-Generation Approach

Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.

Nanoparticle Enabled Formulation And Drug Delivery Solutions

Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

Imagine The Future: Enhanced Oligonucleotide Synthesis

Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.