Newsletter | January 24, 2024

01.24.24 -- A Meditation On mRNA's Regulatory & Reputation Complexities


With today’s global focus and demand for mRNA vaccine development continuing to accelerate at an unprecedented pace, biopharma leaders and clinical trial stakeholders are rapidly adopting new flexible and scalable solutions to ensure the safe delivery of these critical treatments. Click here to learn more about the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential. Learn more.


A Meditation On mRNA’s Reputation And Regulatory Complexities

I see our modality’s capability to be used in the vaccine and ATMP spaces posing some unique challenges for the RNA space moving forward — particularly as we strive to accomplish two key goals as a space: fleshing out the mRNA regulatory paradigm and confronting misinformation in the years ahead.

A Look At siRNA And Market Trends

Small interfering RNA (siRNA) is a class of molecules that play a crucial role in the regulation of gene expression. This article shares how siRNA functions as well as new market research for the field.

How Can Our Knowledge Of CGTs In 2023 Inform Our 2024 Predictions?

2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.


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.

Establishing Analytical Methods For Emerging mRNA-Based Therapies

Here, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substances and drug products.

Harnessing mRNA As A Readout To Develop Robust BioPotency Assays

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


Bringing 180 analytical development, quality control, CMC, and regulatory mRNA specialists to Boston in February, the third mRNA Analytical Development Summit returns to share critical insights into future analytical methods to safeguard your mRNA submissions in 2024 and beyond. Hear from and network with the likes of Eli Lilly, Sanofi, Beam Therapeutics, and GSK as we dive deep into analytical development techniques and challenges within mRNA drug product and drug substance. Download the program.