MANUFACTURING ARTICLES
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![DNA holographic floating at lab Salubrious-GettyImages-2221232296]( "Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right Early")
Patenting RNA Therapeutics In The Age Of AI: What Companies Must Get Right EarlyAs AI transforms RNA discovery, companies must rethink inventorship, obviousness, and patent strategy to secure durable intellectual property protection.
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![Mechanism of Antibody-oligonucleotide conjugates or AOC-GettyImages-1826415391]( "Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process Productivity")
Understanding Therapeutic Oligonucleotide Purification By Anion Exchange Chromatography: From Resin Architecture To Process ProductivityExplore how anion exchange chromatography improves oligonucleotide purification through smarter resin design, better separation, and scalable manufacturing.
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![Production line of vaccine vials automated by robotic arms-GettyImages-1462345800]( "The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)")
The Future Of RNA Manufacturing: Continuous Processing, AI, And Distributed Production (Pt. 3)Continuous manufacturing, AI, modular facilities, and next-generation RNA platforms are reshaping how therapies are produced, scaled, and delivered worldwide.
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![GettyImages-165748654]( "Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?")
Can Oligonucleotide Regulations Keep Up With Manufacturing Innovation?Here in part 2 of my TIDES takeaways, I’ll unpack which guidances we have at our disposal today in the oligo world, and what we can expect in the future.
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![Unlocking a mystery-GettyImages-173547527]( "Unlocking The Future Of mRNA")
Unlocking The Future Of mRNAMany regulatory frameworks and analytical approaches were not originally designed for platforms like mRNA. Addressing these gaps will be essential to fully realize the potential of mRNA technologies.
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![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.
MANUFACTURING VIDEOS
In this Bioprocess Online Live panel discussion, we talk about where the greatest sources of variability are in our downstream processes and how companies should be approaching the question of “how pure is pure enough?"
Listen in on a discussion reviewing key drivers behind the flurry of activity in mRNA therapeutic development and begin to address the rate-limiting risks to mRNA therapeutic development.
Innovation and invention are often limited by challenges in deployment. Here, Cell & Gene Live’s panelists, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics detail how is the field solving these issues. They cover how evolution in the scale up production of novel engineering technologies impacts their near term and long-term deployment.
Chief Scientific Officer and Founder Christian Cobaugh, Ph.D., examines the critical quality attributes of mRNA and LNPs that are pivotal to enhancing drug efficacy and safety.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Residual Plasmid Quantification In Gene Therapy Manufacturing Workflows")
This article details the design and application of a Plasmid DNA - Kanamycin Resistance Gene (pDNA-KanR) kit for residual plasmid quantification in gene therapy manufacturing.
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![GettyImages-1307980860-dna-rna-vial-gene]( "mRNA/saRNA Manufacturing RNA Synthesis Process And Methods")
Venkata Indurthi, Ph.D., discusses key considerations for RNA synthesis processes and methods, their impact on downstream production, and why different projects' needs may vary.
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The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.
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![Genomic sequencing, molecular biology, and genetic data analysis-GettyImages-2153790378]( "The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine")
The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.
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![PCR Plate GettyImages-867159726]( "Meeting Regulatory Requirements With Confidence")
An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
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![Scientist Laboratory sample pipette GettyImages-1354172647]( "Sequencing Of Synthetic Oligonucleotides And Their Impurities")
We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.
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![GettyImages-1288118586 cell development]( "The Future Is Now: CGT Innovation, Challenges, And Perspectives")
As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.
