RNA Supply Chain Articles
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Defining The RNA Therapeutics Industry In 2023
1/16/2023
Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
3/29/2023
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.
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“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA
4/24/2024
It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
11/19/2024
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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Therapeutic Oligonucleotides: Regulations & Quality Standards
5/20/2022
Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
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ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)
3/14/2024
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
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4 Risk Mitigation Strategies For mRNA Production
4/17/2023
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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Assessing Quality Of mRNA Vaccines: Key Considerations
10/12/2022
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
3/11/2024
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.