MANUFACTURING ARTICLES
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![path of exponential growth-GettyImages-2229192052]( "Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing")
Trends In Oligo Scale-Up & Delivery & How They're Impacting ManufacturingHere, 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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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn 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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![GettyImages-1493586956-assay-bottles-laboratory-scientist]( "What You Should Know About USP's Bioassay Updates")
What You Should Know About USP's Bioassay UpdatesThe 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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![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.
MANUFACTURING VIDEOS
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 3, Welch explores the similarities that exist between the art of crafting a high quality violin and the upstream process development work mRNA therapeutics experts are performing today to create the most ideal mRNA drug substance.
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
In this Advancing RNA Live clip, Sail Biomedicines’ Marc Wolfgang gives us a brief primer on the main differences and challenges in developing an IVT reaction for circular RNA, as opposed to linear mRNA.
We work with the world’s leading drug developers to understand disease and create the therapeutics and vaccines that will define the future of medicine.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "mRNA Vaccines And Therapeutics: Current Trends And Perspectives")
Delve into the advancements and transformative impact of mRNA vaccine technology on modern medicine and explore how this technology is revolutionizing healthcare for the future and beyond.
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![GettyImages-1310024666-genetic-digital-dna]( "How Nanoparticle Platforms Are Unlocking Genetic Medicine's Potential")
Explore how the HIT SCAN platform accelerates gene therapy delivery by screening polymeric nanoparticles, enhancing precision and regulatory pathways for next-generation genetic medicines.
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![MRNA Technology-GettyImages-1366661187]( "Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic")
In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.
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![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "Fit-For-Purpose Lipids Can Accelerate, Scale, And Improve RNA-LNP Drugs")
Emerging biotech companies are investing in novel delivery capabilities to address different modalities' needs and extra-hepatic delivery. Explore steps to accelerate commercial nanomedicine delivery.
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![GettyImages-1297146235-dna]( "A Scalable Single-Use Two-Step pDNA Purification Process")
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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![Outsourcing RNA Feature Image]( "Outsourcing RNA-LNP Production: A Key To Competitive Success")
Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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![GettyImages-1279969622-self-injector-injection]( "Manufacturing Challenges With High Concentration Biologics")
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
