MANUFACTURING ARTICLES
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Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing
Here, a panel of experts at the RNA Leaders Conference give a fantastic overview of where we are today and why, as one expert so nicely put it, “This is one of the most fun times to be an oligo scientist or chemist.”
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From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy
In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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What You Should Know About USP's Bioassay Updates
The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.
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New Group Wants 'Phase-Appropriate' Thinking To Retire
Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.
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The Case for Process Simplification in mRNA Manufacturing
Here, I wanted to share a few additional details from Parrella’s presentation about the efforts he and his team at Kernal Biologics made to improve their overall mRNA-LNP COGS. Though he emphasized the amount of opportunity that exists to improve our utilization of costly raw materials/reagents, as he revealed, there are also opportunities for process simplification.
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The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
There were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.
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Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.
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Define a process for your unique mRNA with this interactive guide to pDNA, mRNA, and LNP. Overcome challenges with solutions that can help you develop a next-generation production strategy.
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This review suggests technical remedial options for the production of pDNA and focuses on mRNA synthesis, purification, and encapsulation.
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Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this sensitive measurement, from formulation optimization to cryopreservation techniques.
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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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An outbreak of mycoplasma can halt a biopharmaceutical facility's production for months. Explore the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.