OUTSOURCING ARTICLES
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![MacKay suspension bridge-GettyImages-2281791194]( "Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)")
Bridging The Atlantic: A European Executive's Guide To Building A Successful U.S. RNA Business (Pt. 2)European RNA biotech leaders can accelerate U.S. success by aligning fundraising, partnerships, manufacturing, hiring, and regulatory strategy from day one.
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![GettyImages-1494348289_lab microscope]( "The Delivery Challenge For In Vivo Cell Engineering")
The Delivery Challenge For In Vivo Cell EngineeringAs RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.
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![Pen being used to write a check-GettyImages-173602091]( "Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The Check")
Soliman Says… 5 Questions Every RNA Platform Must Answer Before Investors Write The CheckA practical framework for evaluating whether an RNA company has the science, strategy, scalability, and discipline to become a lasting platform.
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![AI, artificial intelligence, dna research-GettyImages-2192601384]( "Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)")
Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
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![Scattered thoughts-GettyImages-2178092695]( "The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational Friction")
The Hidden Bottleneck In Advanced Therapies Isn't Science… It's Translational FrictionScientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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![DNA target nanodrugs-GettyImages-1405926704]( "RNA Therapeutics: Why CMC Strategy Will Define The Next Decade")
RNA Therapeutics: Why CMC Strategy Will Define The Next DecadeAs RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
OUTSOURCING VIDEOS
There are many different criteria for selecting a CDMO for your mRNA products. Arcturus’ Qian Ruan explains that a product’s stage of development and the specific needs inherent to that phase of development should be an important guide for companies today, especially given the expansion of the outsourcing sector and the wide range of capabilities.
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
Explore how optimized analytical testing, reduced material wastage, and advanced sterile fill-finish technologies can work together to preserve valuable GMP material without compromising quality.
With decades of experience, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory confidence.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1090255620-lab-research-microscope-computer]( "When Is A New Biologic Ready For GMP Production?")
While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.
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![Gene Therapy GettyImages-1164556175]( "Advancing Cell And Gene Therapy Clinical Development In 2023")
Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
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![Documentation Traps]( "Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation")
In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
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![Warehouse management innovative software GettyImages-1355815870]( "Reducing Lead Time, Delivering >99.5% OTIF")
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
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![GettyImages-2183428964 lab]( "Analytical Method Release And Stability Platform For RNA Drug Substance")
We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.
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![GettyImages-1418666846-scientist-lab-test-strip-vial]( "From LAL To rFC: The Evolution Of Endotoxin Testing")
Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
