Newsletter | April 2, 2025

04.02.25 -- Understanding The New MHRA Guidance For mRNA Immunotherapies

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FEATURED EDITORIAL

Learning From Oligos: Delivery & Clinical Strategies For mRNA Therapeutics

Those of us who attended the Alliance for mRNA Medicines’ inaugural Ascent conference last fall had the opportunity to hear from Zdravka Medarova of TransCode Therapeutics on her experiences working in the oligo sector. Here, I summarize some of her learnings and/or suggestions for the encoding RNA field as we set out to develop mRNA therapeutics for oncology.

Understanding The New U.K. MHRA 'Draft Guideline On Individualised mRNA Cancer Immunotherapies'

The U.K.'s MHRA has released a new draft guideline outlining best practices for drug product design, CMC, and manufacturing of mRNA cancer immunotherapies using LNP delivery systems. The public comment period ends March 31.

INDUSTRY INSIGHTS

Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics

Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows including advanced technologies and methodologies to optimize your research and development processes.

De-Risk mRNA Regulatory Approvals

Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.

Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders

Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.

Leveraging Digital Solutions For mRNA Manufacturing, Sustainability

Explore how digital solutions help streamline mRNA manufacturing by reducing costs, improving efficiency, and supporting sustainability by creating paperless processes for emerging therapeutics.

Hepatitis B - Global Clinical Trial Landscape

As Hepatitis B virus (HBV) clinical trials advance, refining therapeutic endpoints and integrating novel treatment strategies are essential to transforming Hepatitis B management.

Navigating The mRNA Regulatory Landscape Post-COVID

While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements, higher dosing needs, and analytical complexities.