ANALYTICAL/QUALITY ARTICLES
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A Guide To Designing mRNA Medicines
A poorly designed mRNA sequence can create ongoing difficulties during downstream clinical development and manufacture. Let's take a closer look at strategies and design software that you can employ.
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Designing Our Way Toward Circular RNA Medicines With AI
The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.
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A Road Map For PAT Monitoring And Control
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
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EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines
The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.
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Do We Really Understand Plasmid Quality's Effects On mRNA Production?
Two experts examine the current guidelines and specs for plasmid DNA and question whether our understanding is sufficient.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
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Nucleases - Are They A Problem For NAB NanosepĀ® Centrifugal Devices?
We examine whether the sample tubes and collection tubes of the NAB Nanosep centrifugal devices contain detectable amounts of DNase or RNase.
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Gene Therapy And Oligonucleotide Compendium
Technical summaries and detailed protocols for purity testing, sizing, sequencing and expression analysis of oligonucleotide-based active agents as well as protein and lipid-based delivery systems.
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Selection And Evaluation Of Hybridization Capture Probes For LC/MS Analysis Of Oligonucleotides
To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.
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Limiting Off-Target Effects Of CRISPR-Based Products
Find out how to enhance CRISPR gene editing specificity by using Next Generation Sequencing to improve sgRNA quality control, addressing off-target effects and ensuring higher sequence fidelity.
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Extending The Lower Limits Of Quantification Of A Therapeutic Oligonucleotide Through Microflow LC-MS/MS
Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.
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Top 5 Approaches To The Bioanalysis Of Oligonucleotides
Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.