MANUFACTURING ARTICLES
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![Future-GettyImages-834713748]( "Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions")
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future DirectionsThis last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
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![Action Plan-GettyImages-2249288072]( "Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing")
Antibody–Oligonucleotide Conjugates, Part 2: ManufacturingLet's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
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![Financial security, wealth protection, money insurance-GettyImages-2288391875]( "Protecting The Platform: Trade Secret Protection For RNA Biotech Companies")
Protecting The Platform: Trade Secret Protection For RNA Biotech CompaniesAs RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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![creativity, innovation-GettyImages-2209122228]( "Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity")
Engineering RNA Agonists For Systemic Immunity Without Systemic ToxicityKrieg believes the answer lies in a deeper understanding of innate immune biology and the design of RNA/DNA hybrid mimics of viral RNA and DNA that are detected by innate immune receptors.
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![economy law of supply and demand-GettyImages-1263079550]( "Is mRNA Manufacturing Overbuilt?")
Is mRNA Manufacturing Overbuilt?mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
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![Justified Risk-GettyImages-2232143649]( "What Oligo Manufacturing Risks Are We Underestimating?")
What Oligo Manufacturing Risks Are We Underestimating?Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos.
MANUFACTURING VIDEOS
Advance from development to manufacturing with expert-led, hands-on, or virtual courses that strengthen process understanding and scale-up skills designed to support every stage of your molecule’s journey.
ALMAC expert Jill Caswell identifies the most overlooked challenges of working with ligase for the chemoenzymatic reaction, as well as the impact this is having today on enzyme engineering and purification.
Listen in on a discussion surrounding questions about chromatography and column-free processes in the development of mRNA vaccines and therapeutics.
The Mobius® MIX single-use mixing systems delivers advanced technology to make and purify plasmid DNA and mRNA.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![cancer cell screening, disease treatment medical-GettyImages-2176920684]( "Using Synthetic ssDNA And dsDNA Templates For CRISPR Editing")
Synthetic ssDNA and dsDNA donor templates boost CRISPR precision, efficiency, and consistency. The right strategy reduces errors, increases HDR, and delivers more reliable results across applications.
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![clinicla-trials-automation-GettyImages-2205446822]( "Reducing Human Variability in Bioanalysis")
Automation removes manual variability, creating consistent, repeatable processes that improve precision, strengthen compliance, and produce more reliable data for critical decisions.
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![GettyImages-1209614664-cell-gene-dna-research-development]( "Quantification Of Large Oligonucleotides Using High Resolution MS/MS")
Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.
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![1100x600 real ebook image Cytiva white background]( "Aseptic Filling By Design: Shaping The Future Of Drug Manufacturing")
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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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![GettyImages-96310150-microfluidics.jpg]( "Accelerated Development Of Self-Amplifying mRNA (saRNA) Vaccines Using Microfluidics")
We showcased the utility of microfluidics to enable low shear, rapid screening of preclinical candidates and the swift advancement to GMP-enabling studies.
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![GettyImages-1269045566-rna]( "Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges")
Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.
