MANUFACTURING ARTICLES
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Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This 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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Antibody–Oligonucleotide Conjugates, Part 2: Manufacturing
Let's delve into manufacturing strategy, conjugation chemistry, process development and scale-up, and purification: the central manufacturing challenge.
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Protecting The Platform: Trade Secret Protection For RNA Biotech Companies
As RNA therapeutics grow more complex and collaborative, trade secrets are becoming an increasingly important part of protecting valuable platform innovation.
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Engineering RNA Agonists For Systemic Immunity Without Systemic Toxicity
Krieg 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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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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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Discover how rising competition, niche patient populations, and evolving therapies are reshaping sterile injectable drug development with cutting-edge technologies.
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Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.
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Get a clear, data-driven look at the biggest pressure points in cell therapy manufacturing. Explore the trends shaping today’s production challenges and where new opportunities are emerging.
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The market for oligonucleotide therapeutics is expanding, and the pipeline is diverse. Gain insight into how you can fast-track your molecule's development with verified synthesizers, columns, and scientific support and expertise.
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mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.
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Discover how hybrid silica technologies ensure stability and high resolution in IP-RP chromatography applications while protecting instrumentation from excessive wear and tear.
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The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.