RNA Outsourcing Resources

  1. 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.

  2. How To Choose The Right CRO For Your Clinical Trial 3/28/2025

    Selecting the right Contract Research Organization (CRO) is critical for the success of a clinical trial. This article outlines essential factors to consider during the selection process.

  3. 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.

  4. New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway 3/1/2024

    Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.

  5. Advancing Cell And Gene Therapy Clinical Development In 2023 7/19/2023

    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.

  6. Improvement Of Self-Amplifying RNA Quality And Potency With IVT Optimization 1/28/2025

    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.

  7. Accelerated Development: Gene Therapy Vs. Small Molecule 12/26/2023

    Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.

  8. 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.

  9. 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.

  10. 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.