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
Join pDNA and mRNA specialists as they discuss innovative mRNA manufacturing solutions for your purification challenges, mRNA stability, and overall product quality.
Learn about an easy to assemble and simple to use solution for laboratory TFF applications, the assembly of the system, and how to perform a continuous diafiltration.
In this Bioprocess Online Live panel discussion explore how two industry experts encourage their CMC and R&D teams to work more closely together to ensure a streamlined transition of a molecule from R&D to process development.
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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![Scientist lab cell and gene dna GettyImages-1305079941]( "Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification")
Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.
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![GettyImages-1386852216 cell therapy]( "Accelerated Development: Gene Therapy Vs. Small Molecule")
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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![GettyImages-1275317360-lab-cell-gene-research-scientist-development-discovery]( "Scale-Up And Manufacturing Of Self-Amplifying RNA-LNPs")
This poster shows the work to scale up COVID-19 self-amplifying RNA-Lipid nanoparticle using PNI developed ionizable lipid and formulation from 0.2, to 50 mg scale using PNI’s Manufacturing Platform.
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![GettyImages-1622519985 cryopreservation, cold chain]( "Optimizing Leukapheresis Cryopreservation For CGT")
Discover how an automated cryopreservation process is reshaping the leukapheresis supply chain and driving progress in the future of cell and gene therapy.
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![GettyImages-508496956-dna]( "mRNA: Challenges And Strategies Related To The DNA Template Process")
Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore insights on DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.
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![GettyImages-1354923731-magnifying-glass-mrna]( "IVT mRNA Encapsulation Efficiency Assessment")
In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.
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![science, teamwork, biotechnology, healthcare innovation-GettyImages-1443966807]( "The Fast Track To Global Expansion: Consistency Across Every Site")
Operational consistency across global facilities protects product integrity and supports growth. Standardized processes reduce risk, minimize variability, and strengthen quality across markets.
