MANUFACTURING 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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![Medical syringe with blue glass DNA helix-GettyImages-1631239019]( "To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem")
To Fight Cancer, Gene Editing Needs To Solve Its Delivery ProblemThe choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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![business challenge, risk-GettyImages-2200659695]( "Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter")
Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next ChapterNow, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
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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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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "What You Should Know About USP's Bioassay Updates")
What You Should Know About USP's Bioassay UpdatesThe United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
MANUFACTURING VIDEOS
Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.
Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus offer insight into CMC considerations and entertain audience questions on the topic.
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.
In this segment of the BioProcess Online Live event CMC, SCALE UP, & THE ROAD TO mRNA REGULATORY APPROVAL, panelists Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share early learnings on the regulatory path.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1127105013-lab-computer-research-scientist]( "Co-Precipitation Of Metal Carbonate Templated Protein Microparticles")
Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.
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![Lipid nanoparticle mRNA vaccine-GettyImages-1418152448]( "Advancing A LNP Formulation To Clinical And Commercial Manufacturing")
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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![iStock-1296757866-research-lab-flask-microscope]( "Understanding Sterile Filtration And Importance Of Prefiltration")
Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.
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![Handshaking-GettyImages-537252274]( "Communication And Transparency In Secondary Supply Qualification")
What should you look for when searching for the right vendor to help you maintain security of raw materials and how can you establish communication that builds confidence?
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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Getting CMC Right For Emerging Technologies")
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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![mRNA GettyImages-1428646288]( "Establishing Analytical Methods For mRNA-Based Therapies")
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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![laboratory DNA GettyImages-1158419934]( "Effectively Scaling Up The Oligonucleotide Manufacturing Process")
Learn how purpose-driven decisions backed by a thorough process that reaps you the largest profit potential over time can result in successful scale up.
