RNA Outsourcing Resources

  1. Navigating Challenges In Progressing Breakthrough RNA Therapeutics 5/14/2024

    RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

  2. 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.

  3. Expectations On The Pathway To GMP For Gene-Modified Cell Therapies 6/21/2023

    Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

  4. Is Not Using A CDMO Slowing Down Your Process Development? 4/27/2020

    Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

  5. Complexing RNPs: Have You Established Your Clinical Acceptance Criteria? 5/13/2025

    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.

  6. Transparent Pricing In Bioanalysis: A Feature, Not A Bonus 3/9/2026

    Unclear CRO pricing leaves small biotechs vulnerable to budget swings. Transparent, itemized costs cut financial risk, sharpen planning, and build trust by setting expectations from the start.

  7. Consolidating The Supply Chain For mRNA 2/12/2024

    Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

  8. Improvement Of Self-Amplifying RNA Quality And Potency With IVT Optimization 2/4/2026

    Explore our study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, and learn how these advancements can enhance RNA-based therapies.

  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. Is Your Biologics CDMO Transparent? 12/12/2025

    Transparency and collaboration with a CDMO are vital for reducing risk and protecting IP. Discover four essential practices, from clear communication to IP safeguards, that help build trust.