RNA Outsourcing Resources

1. 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.

2. cGMP Assurance of Supply Services 1/23/2024

   Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.

3. High-Throughput Platform Propels Gene Editing Therapy Research 3/1/2024

   Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.

4. Lessons In Scaling Lipids Production And Purification 12/13/2021

   The speed at which the pharmaceutical industry is now developing and manufacturing mRNA drug products at large scale is astounding, yet it has highlighted supply chain vulnerabilities to make the required pharmaceutical ingredients such as lipids.

5. 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.

6. Expertise In RNA Therapies: Client Success Stories 2/17/2023

   Learn how to navigate the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.

7. Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics

   What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?

8. 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.

9. Addressing And Adapting To Evolving mRNA Market Trends 7/6/2022

   Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.

10. 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.