OUTSOURCING ARTICLES
-
![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
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.
-
![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
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.
-
![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
-
![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
-
![AI, artificial intelligence, dna research-GettyImages-2192601384]( "Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)")
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.
-
![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
OUTSOURCING VIDEOS
Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.
Explore how IntegriCell™ delivers high-quality, manufacture-ready cryopreserved leukopaks, vital for consistent and reliable cell therapy production.
Optimize mRNA development by learning key strategies for process refinement, critical component identification, and in-process analytics to enhance therapeutic production.
Having worked on both the innovator and CDMO sides of the industry, Advancing RNA LIVE panelist Khaled Yamout outlines where he sees the greatest weaknesses in these critical sponsor-CDMO partnerships and offers guidance.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-1331571740-supply-chain-sourcing-logistics-tracking]( "Built Or Bought? Why Biotechs Are Outsourcing Supply Chain Infrastructure")
Scaling advanced therapies requires navigating extreme logistics and regulatory hurdles. Learn why moving to a flexible, outsourced model is essential for freeing capital and mitigating global risk.
-
![Molecule mRNA-GettyImages-1428646288]( "mRNA Therapeutic Development Through Enhanced IVT Capping Efficiency")
See how Codex HiCap RNA Polymerase supports the production of high-performance synthetic mRNA, paving the way for next-generation mRNA therapies.
-
![GettyImages-547131922 research, regulatory, lab]( "What's Next For ATMP Regulation In EMEA")
Fragmented national regulations for pricing, customs, and reimbursement demand tailored supply chain strategies. Adapting to country-specific hurdles is essential for product integrity and patient access.
-
![scientist laboratory microscope-GettyImages-1253518521]( "Cell And Virus Banking In OV Development And Manufacturing")
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.
-
![GettyImages-1327977866-cell-culture-sample-laboratory]( "Choosing The Best mRNA Manufacturing Strategy")
Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.
-
![GettyImages-2193144544-scientist-cell-culture-in-lab]( "Streamline Cell Therapy Operations By Reducing Requalification")
Redundant requalification tasks can delay late-stage clinical expansion. Standardized protocols reduce repeat validation, lower costs, maintain quality, and support commercialization.
-
![iStock-1051617224-automation]( "Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation")
Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.
