MANUFACTURING ARTICLES
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Top 5 mRNA/RNA Advancements of 2024 (Part 2)
As I took stock of the year behind us, there were five overarching ways in which I saw our industry taking steps forward and finding itself on sturdier scientific and clinical footing. Here, in the second of this two-part article, I continue down this list with my last three takeaways.
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Go From Batch To Continuous RNA Purification With mAb Equipment And QBD
University of Sheffield researchers developed a novel method purify polyadenylated mRNA continuously, which stands to improve productivity and efficiency.
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Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?
Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.
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RNase Control: An Overview With Market Trends
This article shares an overview of ribonuclease (RNase) control and some associated macro market research.
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Commercializing mRNA: 3 "Action Items" To Turn Promising Science Into Real-World Impact
The recent Alliance for mRNA Medicines’ inaugural Ascent conference provided us with a lot of great updates on the mRNA industry’s progress. But throughout each of these specific conversations, there was a shared underlying question: How can we become a less esoteric industry?
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RNA Therapeutics: Navigating The "Holy Trinity" Of Structure, Process, & Biology
During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this scale-up process brings challenges that must be addressed.
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Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
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Explore the automated production of protein microparticles using an innovative method that offers a standardized and scalable solution for co-precipitation in biopolymer particle fabrication.