OUTSOURCING ARTICLES
-
![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
-
![Investment in medical and pharma business GettyImages-1299804755]( "2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends")
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture TrendsAs RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
-
![genetic research, biotechnology, molecular biology, innovation, healthcare solutions-GettyImages-2234236209]( "A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?")
A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
-
![Potter at work-GettyImages-1142834523]( "Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026")
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
-
![GettyImages-1128195910-vial-white-powder-lyophilization]( "Four Reasons You Should Choose Lyophilization for Your Next Project")
Four Reasons You Should Choose Lyophilization for Your Next ProjectLyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.
-
![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, a panel of experts at the RNA Leaders Conference gives a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
OUTSOURCING VIDEOS
Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.
Here, we walk you through our groundbreaking, enzymatic DNA manufacturing process that enables the production of linear DNA templates for IVT mRNA synthesis — without the use of cells.
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.
Gain insights into overcoming the challenges in lipid nanoparticle (LNP) formulation, explore critical aspects of the process and analytical development of LNPs, and much more.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
-
![GettyImages-2036497889-lab-computer-research]( "Collaboration An Untapped Fuel For Driving Biopharma R&D")
Biopharma’s future depends on collaboration. Discover how cross-industry partnerships and shared resources can accelerate innovation, overcome talent gaps, and strengthen the global R&D ecosystem.
-
![4.FILL.LINE.LYDIG_267]( "Scaling Manufacturing Flexibility For Fill-Finish Commercial Success")
Pharma and biotech developers rely on adaptable fill‑finish capacity to meet evolving market demands, scale products from clinical to commercial, and respond rapidly to public‑health emergencies.
-
![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
-
![GettyImages-1327112218 Scientist using a laptop in a laboratory]( "Tackling Antimicrobial Resistance")
Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.
-
![GettyImages-1346675635-laboratory-analysis-research-microscope]( "Minimizing Volume Requirements, Turnaround Time For Compendial Testing")
Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.
-
![Bioanalysis-CRO-GettyImages-1315366428]( "How A Strategic Bioanalysis CRO Partnership Empowers Sponsors")
Choosing the right bioanalysis CRO is vital to avoid costly delays. Sponsors need evaluation strategies that prioritize proven quality, predictable timelines, and submission-ready data.
