Newsletter | April 10, 2024

04.10.24 -- The 3 C's Of mRNA-LNP Raw Material Sourcing

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Webinar: Insights and Strategies for GMP Manufacturing of RNA-Lipid Nanoparticles

The emergence of RNA-encapsulated-lipid nanoparticles (LNPs) has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward? Join David Sokolowski with Cytiva and Jason Coleman with Precision NanoSystems to learn how to leverage manufacturing workflows, processes, and technologies for mRNA vaccine and therapeutic development.

FEATURED EDITORIAL

The 3 C’s Of mRNA-LNP Material Sourcing

In response to an audience poll question gauging which cGMP materials have proven the most difficult to source, our speakers provide additional clarity around which IVT & LNP-related materials today are more “commoditized”.

What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production

Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks. 

Process Development With “The End In Mind” For Startups

We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

INDUSTRY INSIGHTS

How LNP Technology Meets The Delivery Need Of saRNA Vaccines

Explore challenges to the successful development of RNA-based drugs and vaccines as well as the advantages of utilizing lipid nanoparticle technology as a delivery platform for saRNA.

CRISPR Clinical Trials To Follow In 2024 And Beyond

CRISPR therapies are being developed for genetic disorders, cancer, and infectious diseases. Explore which CRISPR clinical trials are worth keeping an eye on this year

mRNA Process And Cost Modeling: A Tool To Optimize Process Development

Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

Practical Applications Of ICH E6(R3): What Do We Need To DO?

This presentation equips stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

Defining A Process For Your Unique mRNA

Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.

Compatible Platforms For Microbial Identification

Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.