Newsletter | January 15, 2025

01.15.25 -- 2025 Forecast For Advanced Therapies

SPONSOR

Though the number of CDMOs with mRNA/RNA capabilities is increasing, many of these are better equipped for large-scale, linear mRNA development. Don't miss Advancing RNA Live on January 21st as our panel shares how mRNA and next-gen RNA modality companies need to be evaluating CDMO platforms. Attendance is free thanks to the support of Cytiva.

FEATURED EDITORIAL

Top 5 mRNA/RNA Developments Of 2024 (Part 1)

In the past few weeks, I’ve shared two articles outlining several RNA executives’ thoughts on advancements from 2024, as well as the challenges facing us in 2025. But why stop there? Below in the first of this two-part article, I share the first two of my five overarching observations from 2024.

2025 Forecast For Advanced Therapies

As we reflect on the lessons from 2024, it’s time to consider what 2025 may hold for the industry. Special attention is given to oligos, mRNA, cell therapies, and AAV.

In What Ways Are We Underestimating LNP Complexity Today?

As the RNA-LNP space continues to diversify beyond linear mRNA and infectious disease vaccines, Kate Zhang of Hopewell Therapeutics, Sumit Luthra of Sanofi, and Ben Muir of BioNTech each address several misconceptions about LNP composition today and how the rise of novel RNA modalities, more advanced mechanisms of action, and novel lipids are challenging our understanding of/work with LNPs today.

Developing Bespoke Antisense Oligonucleotides To Treat Rare Diseases

EveryONE Medicines CEO, Kent Rogers, explains the company’s mission to address a major unmet need in children with rare neurodegenerative diseases, one patient at a time.

INDUSTRY INSIGHTS

Analysis Of LNP Lipids With Evaporative Light Scattering Detection

Jump into this thorough analysis of lipids in LNP formulations using HPLC, a technique crucial for quality control in the production of mRNA vaccines and therapeutics.

CMC And Regulatory Considerations For CRISPR Therapies

This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.

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.

Navigating The Regulatory Landscape For mRNA-Based Therapeutics

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

Digital Solutions Advance Your mRNA Manufacturing Workflow

Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.

Scalable mRNA Affinity Capture

The POROS Oligo dT(25) affinity resin offers a solution for the purification of mRNA by providing efficient purification, high binding capacity, and selectivity, while removing impurities.

SPONSOR

2025 BioPlan's 22nd Annual Survey--Biopharmaceutical Manufacturing

For over 20 years, we continue to be the leader in providing the biopharma industry's most comprehensive benchmarking analysis. We invite you to participate in our 22nd Annual Survey in Biopharmaceutical Manufacturing! For all completed, qualified responses, we'll send an Amazon egift card, a copy of the summary results (mid-2025), and our 2025 Top Trends in Biomanufacturing White Paper.