OUTSOURCING ARTICLES
-
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
-
What Oligo Manufacturing Risks Are We Underestimating?
Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
-
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)
European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
-
The Delivery Challenge For In Vivo Cell Engineering
As RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
-
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check
A practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
-
Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
-
Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.
-
Contract research organizations can be invaluable partners in clinical trials. Dive into the full spectrum of benefits you'll experience by partnering with a globally established and well-resourced CRO.
-
Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
-
Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.
-
Discover how decades of research have propelled mRNA technology to the forefront of therapeutic development and learn how our expertise is advancing mRNA drug development.
-
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.