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 2, Welch outlines how The Game of RISK can serve as a great example for the mRNA therapeutics industry in its long-term quest to standardize the mRNA drug product manufacturing paradigm.
Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.
Discover a new potency bioassay using RT-qPCR to assess relative transcription activity, and learn more about the advantages and limitations of transcriptional assays versus reporter gene assays.
Learn how biopharmaceutical companies can apply proven strategies to overcome hidden complexities in mRNA production, and discover solutions that can help you rapidly design and build a SU facility.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![iStock-1222894162-vaccine-lab-PPE]( "mRNA Vaccine Development: Planning, Workflow, Supply Chain Success")
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
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![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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![GettyImages-1076055404 chromatography, purification]( "Efficiently Select Your Antibody Or Antibody Variant Purification Strategy")
Explore the evolution of antibody therapeutics from monoclonal antibodies to next-gen formats and discover innovative strategies for purifying these complex molecules in today’s landscape.
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![GettyImages-1317300897 Abstract 3d polygonal DNA molecule]( "Contrast In Oligonucleotides")
Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.
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![PCR Plate GettyImages-867159726]( "Meeting Regulatory Requirements With Confidence")
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.
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![SA25-Aseptic-Filling-Workcell-interior-5]( "Standardization And Flexibility In Aseptic Filling")
Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?
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![mRNA GettyImages-1356994684]( "Elevating mRNA Manufacturing Toward GMP-Readiness")
The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
