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
Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus offer insight into CMC considerations and entertain audience questions on the topic.
Nutcracker Therapeutics is a preclinical biopharma company developing multimodal RNA-based therapeutics for HPV-driven tumors, T-cell lymphoma, and Genitourinary tumors. On this episode of the Business of Biotech, Chief Business Officer Geoff Nosrati, Ph.D. offers a comprehensive view of the RNA-based therapeutics landscape and sheds light on what he perceives as an advantageous position at Nutcracker — the capacity to manufacture RNA in-house. If you're curious about the expanding science behind RNA-based therapeutics and their application in biotech, this conversation with a scientist-turned-chief business officer (Nosrati earned his Ph.D. in Biochemistry and Molecular Biology) is a can't-miss episode.
Walk step-by-step instructions through how you can set up the Nova Benchtop System and make your first LNPs.
Three LNP experts from Sanofi, Hopewell Therapeutics, and BioNTech collectively discuss how far we’ve come in understanding the structure of our LNPs while also shedding light on the variables that have the greatest potential of causing shifts in our products’ structure/function.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Crispr gene editing-GettyImages-1139760176]( "The Power Couple: CRISPR And Oligonucleotides")
Drug design using CRISPR depends on long guide RNA (gRNA) sequences. Find out how this match between long oligos and CRISPR works.
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![Gett images-542576580 bio]( "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.
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![GettyImages-1356994684-epigenetics-rna]( "Understanding mRNA Technology As A Platform For Biopharma")
Explore the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.
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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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![GettyImages-1363605023-technician-equipment-technology-cleanroom]( "A Shift Towards Biofluorescent Particle Counters In Manufacturing")
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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![Scientist Laboratory sample pipette GettyImages-1354172647]( "Sequencing Of Synthetic Oligonucleotides And Their Impurities")
We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.
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The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.
