Advancing RNA

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Advancing RNA is a Life Science Connect community focused on the rapidly evolving field of RNA-based therapeutics. It aims to provide valuable insights, discussions, and resources for professionals developing RNA-based drugs. Primary members of the community consist of individuals from biopharma organizations engaged in pre-BLA development, often in the pre-IND discovery stage. The community addresses various challenges in RNA therapy development, including analytical, quality, manufacturing, and regulatory issues. Additionally, Advancing RNA is positioned within the broader Life Science Connect network, allowing members to access additional resources as needed for their RNA therapy development journey. Source

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Scope National
Language English
Country United States of America
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A Q&A On CMC In mRNA Manufacturing

| Advancing RNA
The level of audience engagement during our BioProcess Online Live event CMC, SCALE UP, & THE ROAD TO mRNA REGULATORY APPROVAL was so remarkable, panelists Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus agreed to stick around for an extra 25 minutes to answer audience questions. In this segment of the event, we address a rapid cadence of questions on CMC considerations for mRNA developers.
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Accelerate LNP Manufacturing With Automated And Templated Process Development Services

| Advancing RNA
Manual, operator‑dependent steps have long defined lipid nanoparticle (LNP) formulation, but this approach brings a level of variability that is difficult to control. Real‑time adjustments to flow rates and other parameters introduce inconsistencies that can affect critical quality attributes, including particle size, distribution, and encapsulation efficiency. Even small fluctuations can lead to reduced yields and, for programs using costly nucleic acid payloads, substantial financial loss.
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Enhanced Non-Viral Gene Delivery To Stem Cells With jetMESSENGER® mRNA Transfection Reagent

| Advancing RNA
Get more Advancing RNA insight with our FREE newsletter When scaling-up cell and gene therapy manufacturing to production, biomanufacturers may inherently adopt practices from the lab that are inefficient, cost prohibitive, or unpredictable. Two areas of caution are in the use of non-GMP raw materials and small-volume sampling.
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Major Trends In Next-Gen RNA Engineering: Audience Q&A

| Advancing RNA
We end each Cell & Gene Live by answering our audience’s questions in real time. Here, Nathaniel Wang, CEO and Co-Founder, Replicate Bioscience and Sam Deutch, EVP of Research and Early Development at Nutcracker Therapeutics provide detailed responses to questions regarding managing manufacturing, scalability, and more.
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The Road To Metric-Ton siRNA Production: Is Enzymatic Ligation Ready For Commercial Volume?

| Advancing RNA
Get more Advancing RNA insight with our FREE newsletter Can we actually achieve metric-ton siRNA production today using enzymatic ligation? While the ligation step is highly scalable, upstream "blockmer" synthesis remains the primary bottleneck. Advancing RNA Live panelists Claire McCleod and Jill Caswell discuss the shift from "scaling out" to "scaling up" and lessons learned in the process of achieving larger scale production.
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Complexing RNPs Is A Straightforward Process. Have You Established Your Clinical Acceptance Criteria?

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By Max Sellman
| Advancing RNA
By Max Sellman, Sr. Product Manager Are you effectively controlling the RNP (ribonucleoprotein) complex formation step in your gene-modified cell therapy workflow? When using CRISPR-Cas proteins for gene editing, it’s critical to ensure consistency and quality at each stage of the manufacturing process. The FDA recommends establishing well-defined acceptance criteria for the RNP formation step, as it directly impacts the efficiency, specificity, and safety of genome editing.
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Taming dsRNA Via Innovation In The Supply Chain

| Advancing RNA
Here, Ethris’ Christan Dohmen and Tune Therapeutics’ Stu Sundseth share their take on the most meaningful strategies for reducing dsRNA production. But this discussion also probes a deeper question: Is dsRNA still the most relevant impurity the industry should be chasing, or should focus shift to other contaminants?
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An Introduction To Nova Benchtop IJM System

| Advancing RNA
Get more Advancing RNA insight with our FREE newsletter Learn more about the Nova BT, and discover how you can get one in your lab today! Explore the features of this benchtop system including the dual pump module, mixer module, collection module, software, and additional features. Get unlimited access to: Trend and Thought Leadership Articles Case Studies & White Papers Extensive Product Database Members-Only Premium Content Welcome Back! Please Log In to Continue.
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Exosome Isolation By Tangential Flow Filtration And Size Exclusion Chromatography

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By Jon Lundqvist, David Haylock
| Advancing RNA
By Jon Lundqvist, Cytiva and David Haylock, VivaZome Exosomes, a subset of extracellular vesicles (EVs), play vital roles in intercellular communication and various physiological processes. Their enrichment and concentration from biological samples are essential for studying exosome functions and clinical applications as well as for drug delivery and therapeutic production.
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How Should We Better Interrogate gRNA Design Today?

| Advancing RNA
Advancing RNA Live speaker April Sena emphasizes the need for a collaborative, public safety dataset for chemical modifications to streamline regulatory approvals, while Max De Long points out a potential drug clearance conundrum as we continue to improve our gRNA’s durability and stability. Get unlimited access to: Trend and Thought Leadership Articles Case Studies & White Papers Extensive Product Database Members-Only Premium Content Welcome Back! Please Log In to Continue.
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Advancing RNA Journalists

Welch, Anna Rose