MANUFACTURING ARTICLES
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![Medical syringe with blue glass DNA helix-GettyImages-1631239019]( "To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem")
To Fight Cancer, Gene Editing Needs To Solve Its Delivery ProblemThe choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
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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 gives 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.
MANUFACTURING VIDEOS
Learn about the key aspects of aseptic sampling, appropriate methods and circumstances to perform sampling, and the impact a platform and sample containers can have on assay results and process dynamics.
Explore a state-of-the-art GMP facility focused on CRISPR based Cell and Gene therapies with helping temperature controlled warehouse and multiple synthesis suites.
The TakeOne® is a single-use, pre-assembled sampling device for aseptic collection of samples during upstream and downstream process steps. It is ideal for critical endotoxin, bioburden, sterility and purity checks.
Enjoy the flexibility of user-definable parameters, allowing you to tailor each step of your process, including concentration via continuous flow, washing, resuspension, and final formulation.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-2172807364 vaccine, digital]( "Bridging Advanced Manufacturing, Pharma 4.0, And RNA Therapeutics")
Pharma 4.0 and RNA therapeutics are transforming drug manufacturing. Discover how digital tools, real-time monitoring, and scalable platforms are enhancing quality and efficiency in this evolving landscape.
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![Doctor Preparing Injection Site GettyImages-1379313214]( "How LNP Technology Meets The Delivery Need Of saRNA Vaccines")
Explore challenges to the successful development of RNA-based drugs and vaccines as well as the advantages of utilizing lipid nanoparticle technology as a delivery platform for saRNA.
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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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![Embracing Ongoing Process Verification in Cleaning Validation]( "Toward A Gene Therapy Platform: What's The Best Format Of TFF?")
Evaluate tangential flow filtration (TFF) formats and membrane chemistries for AAV gene therapy processing, assessing performance, scalability, economy, and closed processing options.
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![GettyImages-1355122387 RNA]( "Single-Step Purification Of A 21-mer Oligonucleotide Using Capto™ Q ImpRes Resin")
Explore how the oligonucleotide therapeutics market is advancing with scalable solutions for high-purity purification, supporting global production of life-changing RNA therapies.
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![Gett images-542576580 bio]( "Top 5 Approaches To The Bioanalysis Of Oligonucleotides")
Evaluate the strengths and limitations of each bioanalysis method carefully to choose the most effective strategy for your clinical study.
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![Pall feature image]( "How High-Performance Syringe Filters Extend The Life Of Analytic Instruments And Columns")
This scientific brief reviews how high-performance syringe filters protect and extend the life of analytical HPLC and UHPLC instruments and columns.
