RNA Outsourcing Resources

  1. 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.

  2. 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.

  3. Why Bioanalysis Needs To Break Free From Manual Bottlenecks 9/2/2025

    Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.

  4. Getting CMC Right For Emerging Technologies 12/20/2023

    Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

  5. 5 Outdated Practices Holding Back Modern Bioanalysis 10/20/2025

    Bioanalysis must replace outdated paper, manual processes, and disjointed systems with integrated, automated platforms for continuous validation, efficiency, compliance, and to support complex modern therapies.

  6. Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation 1/9/2026

    Rapid GMP certification is possible with Annex 1-aligned aseptic workflows that reduce contamination risks. Learn how advanced automation and isolator technologies help CDMOs meet regulatory demands.

  7. Enabling CDMOs To Focus On Core Priorities 4/26/2024

    Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.

  8. Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic 11/20/2024

    In this paper, we present the foundation of an mRNA-LNP platform for encoding and expressing therapeutic antibodies in vivo, eliminating the need for costly and time-consuming manufacturing.

  9. Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation 4/30/2024

    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.

  10. mRNA Synthesis Reagents And Manufacturing 8/14/2023

    As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.