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
In this Bioprocess Online Live panel discussion featuring John Stubenrauch, Ph.D., Chief Operations Officer at Nutcracker Therapeutics, and Hari Pujar, Ph.D., Chief Operating Officer at Tessera, explore the impact of and how to potentially mitigate issues posed by raw material variability.
In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.
By eliminating human intervention—the primary risk factor compromising drug sterility and quality—gloveless aseptic processing technology offers manufacturers greater flexibility, safety, and regulatory compliance in their filling operations.
In this segment, Replicate Biosciences’ Andy Geall, Qian Ruan, & Alex Aust identify the most promising technological and raw material innovations that are influencing the drug substance and drug product production processes at CDMOs.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Operator loading nested vials into Microcell vial filler]( "CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics")
CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.
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![Feature Image 1]( "mRNA Product Purification Process Strategies")
Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Explore the pros and cons of each option for mRNA purification.
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![Car-T cell attacking cancer cell-GettyImages-2252478724]( "Automated Cryo‑Processed Leukapheresis For CAR‑T Manufacturing")
Automated, closed cryo‑processing of leukapheresis preserves cell quality and functionality, enabling flexible, reproducible starting material for both autologous and allogeneic CAR‑T manufacturing.
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![GettyImages-958260280-genetic-engineering-genome-editing-helix-dna]( "Genome Editing of Human Primary T Cells With Lipid Nanoparticles")
We show CRISPR/Cas9-mediated knockouts of the T cell receptor and explore multi-step LNP engineering to produce TCRɑβ KO CAR T cells, a promising approach towards allogeneic CAR T cell therapy.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "CAR T Set The Pace So All Can Win The Cell Therapy Race")
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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![GettyImages-2194013442-laboratory-scientists-computer-evaluating]( "5 Key Considerations For Companies Outsourcing Process Development")
Venture capital in biotech remains strong post-pandemic, especially in cell and gene therapies. Discover five key factors to help companies choose between in-house and outsourced process development strategies.
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![GettyImages-2193391345-cryopreservation]( "How Operational Efficiency Shapes Late-Phase Manufacturability")
Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.
