MANUFACTURING ARTICLES
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![Future business concept-GettyImages-1390149628]( "5 Critical Regulatory Topics To Watch In The Oligo Sector")
5 Critical Regulatory Topics To Watch In The Oligo SectorThough our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.
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![DNA target nanodrugs-GettyImages-1405926704]( "Beyond Gene Silencing: Harnessing Regulatory RNAs To Increase Gene Expression In Haploinsufficient Disease")
Beyond Gene Silencing: Harnessing Regulatory RNAs To Increase Gene Expression In Haploinsufficient DiseaseCan RNA therapeutics increase — not silence — gene expression? Regulatory RNA-targeting ASOs may redefine treatment for haploinsufficient diseases.
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![Small interfering RNA, sirna, mrna, crispr-GettyImages-1409578453]( "Beyond The m⁷G Cap: How Non-Canonical RNA Capping Could Expand RNA Therapeutics")
Beyond The m⁷G Cap: How Non-Canonical RNA Capping Could Expand RNA TherapeuticsNewly discovered non-canonical RNA caps are reshaping RNA biology and could inspire the next generation of more precise, programmable RNA therapeutics.
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![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.
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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.
MANUFACTURING VIDEOS
Enjoy the flexibility of user-definable parameters, allowing you to tailor each step of your process, including concentration via continuous flow, washing, resuspension, and final formulation.
BioNTech’s Ben Muir shares a high-level overview of the LNP preclinical research advances that are the most exciting/promising today — while also reminding us of a few important caveats that accompany early-stage research.
Three LNP experts from Sanofi, Hopewell Therapeutics, and BioNTech collectively discuss how far we’ve come in understanding the structure of our LNPs while also shedding light on the variables that have the greatest potential of causing shifts in our products’ structure/function.
As a field, we’ve been aligned around CQAs for our mRNA drug substances. However, differences in translation between highly similar mRNAs (i.e., (same sequence, same design, different manufacturers) raises the question of whether we’re missing any QAs/CQAs. Here, Advancing RNA Live panelists Elaine Peters and Ilya Shestolapov share their take.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![GettyImages-1026622810 chromatography column]( "How To Navigate Through The Jungle Of Columns?")
Whether prioritizing mass spectrometry compatibility or loading capacity, understanding the specific trade-offs between IP-RP, AEX, and SEC methodologies is essential for successful characterization.
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![Scientists working in lab-GettyImages-542935478]( "Effective Environmental Monitoring And Control In Pharma Operations")
A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.
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![MicroSEQ Rapid Microbial Identification System]( "Compatible Platforms For Microbial Identification")
Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.
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![GE-fasttrak]( "Optimizing Process Efficiency In Upstream Manufacturing")
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
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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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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
