MANUFACTURING ARTICLES
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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.
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RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation
From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Reach new heights in mAb production with a high-intensity perfusion CHO medium designed to support consistently high product yield and quality in continuous perfusion cultures using CHO-K1 cells.
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Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.
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Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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Moving mRNA-LNP production from lab to GMP scale exposes tensions among formulation consistency, regulatory expectations, and facility safety, while automation offers ways to resolve them.
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Learn best practices for high-resolution analysis of IVT RNA using automated capillary electrophoresis. Improve accuracy and precision in quantifying critical quality attributes.
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Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.
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Prioritize operational efficiency over early-stage flexibility to scale advanced therapies. Standardized workflows and qualified shipping lanes reduce variability for predictable late-phase success.