MANUFACTURING ARTICLES
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Trends In Oligo Scale-Up & Delivery & How They're Impacting Manufacturing
Here, 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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From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy
In 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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What You Should Know About USP's Bioassay Updates
The 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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New Group Wants 'Phase-Appropriate' Thinking To Retire
Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.
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The Case for Process Simplification in mRNA Manufacturing
Here, 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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The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future
There 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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
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Bringing allogeneic cell therapy to patient care will require flexible, closed, and automated solutions to support the treatment options and increasing scale of the industry.
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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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Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.
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Advanced manufacturing can produce new technology like mRNA within cGMP requirements and demanding timelines. What does this mean for scalability and continuous manufacturing?
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A lack of standardization and cost-effective techniques for manufacturing and analytics for product characterization create CMC challenges for mRNA-based products.
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Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.