RNA Manufacturing Resources
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Purification And QC Of An RNA 21‑Mer Oligonucleotide Via LC‑MS
1/27/2026
Learn how buffer choice, gradient strategy, and pretreatment steps influence recovery, purity, and resolution when purifying a native RNA oligo, with analytical confirmation and practical guidance.
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Multivariate Inter-Stage Batch Profile Monitoring And Future State Estimation
2/3/2022
How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?
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How Robotic Isolator Technology Aligns To Annex 1 Principles
4/28/2025
Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines
1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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Metabolite ID And Relative Quantification Of Oligonucleotides In Plasma
3/4/2022
This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.
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Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective
6/22/2020
This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.
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Comprehensive Characterization Of Oligonucleotides And Related Impurities
7/29/2026
A two-dimensional LC/MS strategy improves the separation of coeluting oligonucleotide impurities. High-resolution sampling and automation enable deeper characterization of low-level variants.
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Optimizing siRNA Therapeutics: Addressing Manufacturing Complexities
3/21/2025
Discover key strategies to optimize siRNA therapeutics by addressing critical nonclinical and manufacturing challenges for a smoother path to commercialization.
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Aseptic Filling By Design: Shaping The Future Of Drug Manufacturing
3/20/2026
Modern therapies demand higher sterility assurance and flexible operations. Discover how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.
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New To mRNA Manufacturing? Considerations For Starting
6/15/2022
Explore considerations for starting mRNA manufacturing related to the following topics: DNA template, mRNA product - IVT, mRNA product - purification, LNP encapsulation, and fill-finish.