OUTSOURCING ARTICLES
-
![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
-
![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.
OUTSOURCING VIDEOS
Max De Long, April Sena, and Venkat Krishnamurthy share their perspectives on the current “health” of CDMO SPOS and enzymatic ligation platforms, while also highlighting the “red flags” to look out for when taking stock of a CDMOs capabilities.
Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
Three Advancing RNA Live panelists share their greatest needs in outsourcing partnerships for mRNA/RNA-LNP products and where sponsors should be the most prescriptive when drafting an MSA with an outsourcing partner.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-618725044 lab, tablet, teamwork]( "Starting Smart: Building Early CGT Supply Chains")
Discover how building a scalable, compliant supply chain can set your CGT program up for long-term success and avoid risks that could derail progress down the line.
-
![GettyImages-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
-
![GettyImages-1183908006 bioanalysis]( "5 Outdated Practices Holding Back Modern Bioanalysis")
Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.
-
![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
-
![iStock-528606286-handshake-partnership-partner-agreement]( "Is Your Biologics CDMO Transparent?")
Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.
-
![GettyImages-1355122387 RNA]( "Improvement Of Self-Amplifying RNA Quality And Potency With IVT Optimization")
Explore our study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, and learn how these advancements can enhance RNA-based therapies.
-
![2.FREEZER.LYDIG_027]( "Protecting Product Integrity Through Cold Chain")
Reliable temperature‑controlled storage, monitoring, and safeguards keep sensitive materials stable from fill to patient, protecting quality, preventing degradation, and ensuring safety throughout the cold chain.
