MANUFACTURING ARTICLES
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![vacation-GettyImages-1430503053]( "New Group Wants 'Phase-Appropriate' Thinking To Retire")
New Group Wants 'Phase-Appropriate' Thinking To RetireDecisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.
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![Creative problem solving, skill, solution-GettyImages-2184276582]( "The Case for Process Simplification in mRNA Manufacturing")
The Case for Process Simplification in mRNA ManufacturingHere, 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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![cars driving on a bridge-GettyImages-1167795076]( "The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future")
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic FutureThere 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.
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![Athletic Jump-GettyImages-130409478]( "Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide Manufacturing")
Beyond Solid-Phase Synthesis: The Momentum of Oligonucleotide ManufacturingOverall, there were three main takeaways I gleaned from our conversation that suggest the oligo sector, though more established than its mRNA cousin, is not comfortable with the status quo and is actively trying to grow beyond the limits of its current manufacturing paradigm. Here in part 1, we’ll start with my number one takeaway, which also comes equipped with a bit of history as to how we find ourselves at our current juncture.
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![DNA strands, genetic biotechnology, gene cell-GettyImages-2154784301]( "Inside Arbor Biotech's In Vivo Gene Therapy Approach")
Inside Arbor Biotech's In Vivo Gene Therapy ApproachFollowing recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.
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![GettyImages-2152639905-five-5]( "5 Takeaways From The MHRA mRNA Guidance")
5 Takeaways From The MHRA mRNA GuidanceHaving read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA.
MANUFACTURING VIDEOS
Ensure your mRNA's stability and effectiveness post-transcription with advanced filtration and chromatography techniques to enhance purity and recovery, which delivers high-quality mRNA for superior therapeutics and vaccines.
Advancing RNA Live panelists identify what is “as good as we can get right now” in terms of understanding our IVT reactions while sharing their ideas on how we can arrive at a future that includes real-time monitoring of our drug substance production processes.
Hosted by Cell & Gene Collaborative Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 5, Welch dives into the separate — but strikingly similar — worlds of fly fishing and mRNA R&D. In particular, she explains how a fly fisherman’s strategies to catch a fish relate to the work of mRNA scientists as they strive to identify the most appropriate immunogenicity profiles for their mRNA vaccines or therapeutics.
Join our webinar on scaling the CTS LV-MAX System in bioreactors, covering transfection scalability, Thermo S.U.B. advantages, and DynaSpin’s efficient gene therapy integration.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![GettyImages-1444551560-filling-aseptic-fill-finish-line]( "Scaling Personalized Medicines For Flexible Aseptic Filling")
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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![GettyImages-1307980860-dna-rna-vial-gene]( "mRNA/saRNA Manufacturing RNA Synthesis Process And Methods")
Venkata Indurthi, Ph.D., discusses key considerations for RNA synthesis processes and methods, their impact on downstream production, and why different projects' needs may vary.
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![GettyImages-2183428951-biomanufacturing]( "The Evolution Of Nucleotide Production")
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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![Syringe and vaccine vial-GettyImages-1855924776]( "Future-Proofing mRNA Drug Manufacturing: The Value of Continuous Improvement")
With so many uncertainties permeating the mRNA market, this largely preclinical industry is still seeking answers on how to reach successful therapeutic development. Identifying optimizations, both sequence-dependent and otherwise, to enhance the manufacturing process is crucial for advancing mRNA product development, which holds vast potential to address a wide range of indications.
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![laboratory scientist data iStock-1209661942]( "Ultrafiltration Devices And Plates Offer Higher-Throughput Options For Cloning And PCR Workflows")
Learn how ultrafiltration devices in various steps of the cloning workflow can provide a more streamlined process compared to traditional methods of subcloning PCR-generated fragments.
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![A Versatile Method For Capsule And Depth Filtration]( "A Versatile Method For Capsule And Depth Filtration")
Learn about a solution that can provide a simple, easy, and versatile method for capsule and depth filtration, allowing a quick, efficient move from cell harvest to purification.
