RNA Outsourcing Resources
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mRNA: How To Build A Custom Program Using CDMO Services
1/4/2023
Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas.
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How To Build Effective Clinical Trial Oversight And Leadership
7/14/2025
In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.
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Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs
8/14/2023
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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The Sponsor's Clinical Development Handbook For Gene Therapy Trials
6/21/2024
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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mRNA Manufacturing And Formulation
11/15/2022
From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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The Execution Stage Of Technology Transfer
5/2/2024
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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Avoiding The Pitfalls Of LNPs And Complex Formulations
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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Addressing Challenges In mRNA Drug Development And Manufacturing
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions
4/21/2021
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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What Is The Role Of CROs In Drug Development?
5/13/2025
CROs are not just facilitators but strategic innovators essential for delivering new therapies to patients efficiently and safely.