MANUFACTURING ARTICLES
-
Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?
Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future.
-
Unlocking The Future Of mRNA
Many regulatory frameworks and analytical approaches were not originally designed for platforms like mRNA. Addressing these gaps will be essential to fully realize the potential of mRNA technologies.
-
The Hidden Bottleneck In Advanced Therapies Isn't Science⦠It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
-
RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
-
Rethinking The Oligonucleotide Backbone: Why RNA Therapeutics May Need A New Molecular Design Framework
New backbone chemistries could unlock greater control over delivery, specificity, and safety, expanding the molecular design space for RNA medicines.
-
RNA Platforms: What Transfers And What Breaks
A practical framework for distinguishing reusable RNA platform knowledge from biology-specific unknowns as therapeutics expand into new tissues and indications.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
ISO 21973 establishes global best practices for transporting cell and gene therapies, ensuring quality, safety, and consistency across complex supply chains critical to patient outcomes.
-
RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.
-
The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
-
Modern therapies demand higher sterility assurance and flexible operations. Discover how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.
-
Examine how a centralized logistics hub can transform the distribution of ATMPs, ensuring that sensitive therapies reach patients safely and efficiently.
-
Cell & gene therapies are rapidly outpacing the industry's limited manufacturing capacity. Learn more about the developing network of supply chain centers built to support this growing client base.
-
Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.