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
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.
See how Pall innovative and time-saving life science research products simplify and speed up your critical workflow steps and allow for faster data analysis and results.
Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.
In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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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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![Molecule]( "mRNA-LNP Nucleic Acid Assessment From Distinct Formulations")
Review a showcase of a high throughput robust analysis for nucleic acid integrity and size assessment of mRNA-LNP samples using a multi-capillary system and purity and integrity analysis kit.
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![Laboratory-analysis-GettyImages-1385463753]( "Tips For Viral Vector Production")
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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![GettyImages-96310150-microfluidics.jpg]( "Accelerated Development Of Self-Amplifying mRNA (saRNA) Vaccines Using Microfluidics")
We showcased the utility of microfluidics to enable low shear, rapid screening of preclinical candidates and the swift advancement to GMP-enabling studies.
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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.
