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
Explore best practices for developing a QC method for identification and impurity analysis of oligonucleotides, as well as tips on mitigating risk by using compliant instrumentation and software.
Explore the features of this benchtop system including the dual pump module, mixer module, collection module, software, and additional features.
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 Bioprocess Online Live panel discussion, we identify the manufacturing-centric efficiencies taking shape today that could encourage us to think differently about the mRNA manufacturing paradigm in the future.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages- 1180547354 trial data]( "Understanding CRISPR Clinical Trials: Your Questions Answered")
CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
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![MicroSEQ Rapid Microbial Identification System]( "Compatible Platforms For Microbial Identification")
Reduce the time-to-results for microbial identification by taking advantage of the shorter run cycle and off-instrument data analysis provided by this optimized and validated workflow.
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Today’s novel solutions and technologies can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.
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![mRNA iStock-1295693748]( "Efficient, Scalable Purification Of mRNA By Affinity Chromatography")
Increasing demand for mRNA as a therapeutic product requires efficient, scalable purification methods. Here, a monolithic stationary phase is used to purify mRNA from a capping mix of Luc2 RNA.
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![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here, we explore this from a biopharma process development and manufacturing perspective.
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The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
