ARW ON RNA
Shifting Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. In the first of this two-part article, I outline a few of these important manufacturing and outsourcing considerations that must accompany our shift to smaller scales.
OUR EXPERT NETWORK
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![DNA Code-GettyImages-165657815]( "EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides")
EMA Issues Draft Guideline On The Development And Manufacture Of OligonucleotidesThe EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.
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![bottle and syringe serum drug-GettyImages-1337025915]( "This Digital Twin Approach Aims To Optimize ATMP Production")
This Digital Twin Approach Aims To Optimize ATMP ProductionManufacturing therapeutic cells includes labor-intensive processes. These researchers are developing a way to increase yields through cost-effective expansion protocols.
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![mRNA GettyImages-1356994684]( "Strategies To Address FDA CMC Trends For mRNA Therapies")
Strategies To Address FDA CMC Trends For mRNA TherapiesA CMC consultant shares learnings from recent interactions with FDA regulators. The discussion primarily addresses prophylactic mRNA-LNP vaccines, though many considerations apply equally to therapeutic mRNA-LNP applications.
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![Steven Kelly_300CMYK]( "Where Are They Now? Carisma Therapeutics")
Where Are They Now? Carisma TherapeuticsIn three years, Carisma Therapeutics has gone public, entered a broad collaboration with Moderna, and ceased development of its original CAR-Macrophage candidate, in favor of CAR-Monocyte therapies. Carisma expects to release CT-0525 Phase 1 data by the end of 2024.
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![Scientist in a cleanroom laboratory-GettyImages-675822682]( "Wish SUS Cost Less? Survey Says Your Peers Do, Too")
Wish SUS Cost Less? Survey Says Your Peers Do, TooBioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
WEBINARS
MEET ARW
I’ve spent the past 10 years building relationships across the biologics and advanced therapies industry. In addition to hosting conversations and writing thought leadership articles, my goal as the editorial and community director for Advancing RNA is to find creative ways for the RNA (and broader ATMP) space to discuss, debate, and ultimately define a mature RNA therapeutics industry.
Start the conversation by following me on LinkedIn!
ARW ON BUSINESS OF BIOTECH
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![24_01_BoB_1280x720_Ep217]( "Pivoting To RNA With Circio's Dr. Erik Digman Wiklund")
This week, it’s another “Business of Biotech-meets-Business-of-RNA” takeover with Circio CEO Erik Digman Wiklund, Ph.D. and guest co-host Anna Rose Welch of Advancing RNA. While Circio’s legacy is in cancer immunology (it still boasts a cancer vaccine candidate targeting KRAS driver mutations), the company made a bold pivot, of sorts, when it committed headlong to the circular RNA future. Now, it’s in the throes of fine-tuning a platform for the development of novel circRNA medicines for rare disease, vaccines, and cancer.
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![24_01_BoB_1280x720_Ep216]( "mRNA Upstarts With Radar Therapeutics' Sophia Lugo and Eerik Kaseniit, Ph.D.")
Guest co-host Anna Rose Welch of Advancing RNA fame joins us on this week’s Business of Biotech podcast for a conversation with the leaders of RNA upstart Radar Therapeutics. The company’s co-founders, Eerik Kaseniit, Ph.D. (CSO & President) and Sophia Lugo (CEO), are making waves in the mRNA therapeutics space on the heels of the invention of a precision-expressed mRNA technology that laid bare the path to Radar’s inception.
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![24_01_BoB_1280x720_Ep199]( "Circular RNA with Orna Therapeutics' Tom Barnes, Ph.D. and Advancing RNA's Anna Rose Welch")
As if Orna Therapeutics' CEO, Thomas Barnes, isn't enough to draw you in to the Business of Biotech, we teamed up with Advancing RNA Editorial & Community Director Anna Rose Welch to co-host this week's episode. Together, Anna Rose and I press Dr. Barnes on his transition from academia to biotech, the therapeutic proposition of circular, or "O", RNA and why it holds great potential to best linear RNA constructs, the novel, platform- and partnership-based approaches Orna is taking to address B-cell lymphomas and Duchenne Muscular Dystrophy, viral vector and lipid nanoparticle complexity, and a whole lot more.
VIRTUAL EVENTS
- Can We Do Better? Current & Future Realities of mRNA Process Development
- Opening The "Black Box" Of The mRNA Regulatory Paradigm
- Got Raw Materials? The State Of The mRNA Supply Chain
- mRNA For Cancer Immunotherapy: 2024 Outlook
- mRNA Update: Beyond Prophylactic Vaccines
- Risk Reduction In mRNA Therapeutic Development
NEWSLETTER ARCHIVE
- 10.02.24 -- FDA's Platform Guidance Raises Questions For mRNA Makers
- 09.26.24 -- Industrializing mRNA Therapeutics
- 09.25.24 -- Pivoting To RNA With Circio's Dr. Erik Digman Wiklund
- 09.23.24 -- Nanoparticle Enabled Formulation And Drug Delivery Solutions
- 09.18.24 -- Two "Spicy" Takeaways On The FDA's Platform Designation Guidance
- 09.17.24 -- Outsourcing Strategies To Maximize RNA-LNP Success