RNA Manufacturing 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. Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development 10/7/2024

   Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.

3. Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing 6/12/2023

   Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

4. 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.

5. The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine 2/18/2025

   The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

6. How Data Analytics Accelerates Transition To Bioprocessing 4.0 4/7/2023

   Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

7. Purifying Plasmid DNA Using A Modern Chromatography Resin 2/5/2020

   Through an industry collaboration, Cobra and Cytiva were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.

8. 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.

9. End-To-End Solutions To Support Your mRNA Therapeutics Workflow 7/18/2023

   Take a step-by-step review of the mRNA therapeutics journey and find out how you can meet the critical process, scale, quality and regulatory needs from development to commercialization.

10. Understanding Sterile Filtration And Importance Of Prefiltration 4/27/2022

    Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.