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
Dive into this overview of vaccine development and learn how to overcome some key challenges with Precision NanoSystems Inc.'s field application scientist, Dr. Ian Villamagna.
Unlock next-generation nanoparticle and LNP manufacturing. Achieve high throughput, minimal waste, and superior quality with a compact, automated, and contamination-controlled system.
Though there are a lot of exciting advancements being made with novel lipid chemistries, CMC Consultant Sujit Jain provides an important reality check for us: These innovations break established platforms, requiring fresh process development, complex impurity profiling, and new vendor qualifications.
Looking to enhance performance and manufacturing from your DNA backbone without the regulatory concerns? Gain advantages over legacy plasmid DNA backbones and minicircles.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![CRISPR Gene Editing]( "The Benefits Of Cas9 mRNA: Precision, Control, Cost Efficiency")
Unlock the full potential of CRISPR-Cas9 gene editing with high-purity Cas9 mRNA, the emerging choice for safer and more efficient genome engineering.
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![Why You Need Spare Parts On Hand For Pharma And Lab Equipment]( "Why You Need Spare Parts On Hand For Pharma And Lab Equipment")
Advanced spare parts planning can reduce downtime. Learn why precise component specifications matter and how seemingly identical parts can differ significantly in quality, performance, and failure risk.
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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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![Outsourcing RNA Feature Image]( "Outsourcing RNA-LNP Production: A Key To Competitive Success")
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![Vaccine Manufacturing GettyImages-1384850913]( "Modeling The Economics Of Vaccine Manufacturing")
Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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![GettyImages-163113211-south-africa-globe]( "Building Local Biomanufacturing Capacity In South Africa")
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
