Newsletter | September 18, 2024

09.18.24 -- Two "Spicy" Takeaways On The FDA's Platform Designation Guidance

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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 whitepaper provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products. Learn more here.

FEATURED EDITORIAL

Two "Spicy" Takeaways On The FDA's Platform Designation Guidance

Over the past few weeks since the guidance was released, I’ve spent some time listening to industry conversations and reading the guidance and related articles. In the following series of articles, I’ll share a few general impressions and (slightly spicy) thoughts I’ve been mulling over in response to the draft guidance.

INDUSTRY INSIGHTS

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying ways to make processes more sustainable. Learn how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and explore the advantages and limitations of transcriptional assays versus reporter gene assays.

Comparing Real-Time And Digital PCR Technologies

Which PCR technologies are the most effective? Examine digital PCR (dPCR) and real-time or quantitative PCR (qPCR) to determine the best choice for your labs.

mRNA Product IVT Process Insights

In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.

The Future Of mRNA: Four Key Focuses For Industry

Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry.

Key Benefits Of PCR-Based mRNA Manufacturing For Clinical Development

To unlock the potential of your mRNA therapies and accelerate your development and manufacturing program, discover the benefits of a novel PCR-based mRNA drug substance manufacturing process.