MANUFACTURING ARTICLES
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![business challenge, risk-GettyImages-2200659695]( "Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next Chapter")
Striking The Right Balance: The Critical Discussions Driving The mRNA Industry's Next ChapterNow, I cannot claim that I or any of the panelists at CASSS have or had access to a real crystal ball that will show us the future. However, what did come through these discussions loud and clear is that the future of our industry must include “balance.” Here, I’ll unpack a few ways the theme of “balance” presented itself — and no doubt will continue to present itself in the future — as well as how the panelists see us achieving this necessary balance.
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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.
MANUFACTURING VIDEOS
There are many different criteria for selecting a CDMO for your mRNA products. Arcturus’ Qian Ruan explains that a product’s stage of development and the specific needs inherent to that phase of development should be an important guide for companies today, especially given the expansion of the outsourcing sector and the wide range of capabilities.
Discover the benefits of an LNP system that offers unparalleled durability and sustainability. Eliminate wear parts, plastic waste, and running costs with a system designed for long-term performance and minimal environmental impact.
In this Bioprocess Online Live panel discussion, experts share the most important factors to consider when assessing the manufacturability of novel linear mRNA candidates in order to bring forward the most successful lead candidates.
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![E. Coli 450x300]( "Combining Cell Clearance And Sterile Filtration Functionality For Improved Clarification Of Mammalian Cell Cultures")
This application note demonstrates systems that have proven quite useful for clarification of mammalian cell cultures such as CHO-cells, by combining the cell clearance and sterile filtration functionality in a single device.
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![AM STABTEST Waters Inc]( "A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System")
CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
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![GettyImages-163113211-south-africa-globe]( "Building Local Biomanufacturing Capacity In South Africa")
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.
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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![The-Column-2]( "A Proven Platform For Solid-Phase Oligonucleotide Synthesis")
Facilitating oligonucleotide synthesis with state-of-the-art equipment and process support is critical to maximizing oligo production and achieving consistency at scale.
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![GettyImages-1269045566-rna]( "Standardize Scale-Up And Reduce Time To Market With Mixing Cartridges")
Despite the momentum of the RNA-LNP therapeutic market, significant manufacturing challenges remain. However, the right mixing could solve three of these key challenges regarding instrumentation.
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![iStock-1295693748-mRNA]( "mRNA Manufacturing Workflow")
Therapies based on messenger RNA, such as mRNA vaccines, have revolutionary potential. Learn more about key objectives, considerations, and strategies in mRNA manufacturing.
