OUTSOURCING ARTICLES
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![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.
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![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.
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![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.”
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![Outsourcing-GettyImages-467648692]( "Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond")
Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And BeyondContract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.
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![cars driving on a bridge-GettyImages-1167795076]( "The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future")
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic FutureThere were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
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![PCR machine Thermocycler for DNA or RNA quantification-GettyImages-1227432556]( "A Flexible Mindset For Bridging Between Cell-Based Assay Groups")
A Flexible Mindset For Bridging Between Cell-Based Assay GroupsTransferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
OUTSOURCING VIDEOS
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
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.
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.
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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1443973272 research]( "Going Global: How Working With A CRO Can Benefit Clinical Trials")
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.
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![GettyImages-2196170530 isolator]( "Benefits Of Isolator Technology In Fill-Finish")
Isolator technology enhances sterility assurance, reduces contamination risk, improves operator safety, and supports regulatory compliance, making it essential for modern aseptic fill-finish operations.
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![GettyImages-1869998960 patient, doctor, clincial trial]( "Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer")
This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![GettyImages-1354171846-lab-research-development]( "Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics")
What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
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![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.
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![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.
