RNA Outsourcing Resources

  1. CDMO Or No CDMO... That Is The Question 12/12/2025

    Success depends on assessing internal capabilities and knowing when outsourcing can accelerate timelines. Learn how strategic decisions reduce risk, avoid costly delays, and keep your organization competitive.

  2. Biologics CDMO: 3 Qualities Often Overlooked 12/12/2025

    A partnership can deliver more than process support. Transparency, regulatory expertise, and IP protection are critical benefits that safeguard your autonomy and innovation while enabling global success.

  3. 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.

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

    Ensuring consistency and quality at every manufacturing stage is critical for CRISPR-Cas gene editing. To achieve this, the FDA recommends establishing well-defined acceptance criteria for RNP formation.

  5. When Is A New Biologic Ready For GMP Production? 1/17/2023

    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.

  6. All You Need To Know About GMP Manufacturing Of mRNA-LNP Drug Products 10/13/2026

    Moving mRNA-LNP production from lab to GMP scale exposes tensions among formulation consistency, regulatory expectations, and facility safety, while automation offers ways to resolve them.

  7. Expanding Supply Chain Solutions With Vein-To-Vein Offerings 4/7/2023

    Leveraging a partner experienced in controlled temperature GMP-compliant storage, secondary packaging/labeling, and kit production is critical to advance your CGT project to market.

  8. Safe, Scalable And GMP-Ready DNA 4/24/2026

    Cell‑free synthetic DNA provides a scalable, safer alternative to plasmids by eliminating bacterial risks, simplifying quality control, and enabling complex sequences under GMP‑aligned conditions.

  9. 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.

  10. Expand Trial Footprints Without Expanding Cryopreservation Risk 8/3/2026

    Transitioning from fresh to frozen starting material stabilizes cell therapy inputs, but isolated workflows introduce risk. Integrated logistics safeguard quality as trial footprints expand.