Featured Editorial
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Developing & Manufacturing Oligonucleotides: An Overview
8/22/2024
An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.
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Is This The Hardest Question Facing mRNA Therapeutics Makers?
8/18/2024
As I’ve been reminded on a few different occasions, there is a difficult truth we may need to wrap our brains around in certain situations: Just because we can make an mRNA therapy for an indication, doesn’t necessary mean we should — or that the patient population will necessarily want it or be able to access it.
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A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services
8/15/2024
These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development.
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Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise
8/12/2024
BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.
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Translatability: The Challenge Keeping mRNA Therapeutics Execs Up At Night
8/9/2024
It goes without saying that there’s a lot we need to understand about how our drug products’ composition (i.e., lipid/mRNA ratio) analytical profile, and manufacturing process impact their potency and safety. But I also appreciated the panels’ focus on the importance of gaining a clearer understanding of the biological factors that influence the strength, durability, immunogenicity, and overall deliverability of our RNA therapeutics in vivo.
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Scaling RNA Production From The Lab To The Clinic
8/9/2024
Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.
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A Perfect Pair? Combining Keytruda And mRNA Therapy To Optimize Bladder Cancer Outcomes
8/7/2024
AdventHealth's Guru Sonpavde, MD credits the patient-centric trial design, the city’s diversity, and the staff’s expertise with executing the trial for giving bladder cancer patients a chance at a quicker and fuller recovery.
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Rising Allure And Critical Considerations Of Point-Of-Care Processing
8/1/2024
Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.
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Bridge RNAs: Principles, Applications, And Challenges
8/1/2024
Bridge RNAs are structured noncoding RNAs that facilitate programmable recombination between target and donor DNA, enabling precise genomic rearrangements. A significant advantage is their modularity.
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Collaboration Key To Going "Out On A Limb" For Nonviral mRNA Delivery
7/31/2024
As the members of this panel at the World Vaccine Congress emphasized, they see great — and in some cases untapped — opportunities for collaboration to better advance nonviral delivery of a wide variety of RNA therapeutics.