RNA Manufacturing Resources

  1. 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.

  2. Overcome The Supply Chain Complexities Of Vaccine Development 11/18/2022

    Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.

  3. Process Development Considerations For RNA-LNP Therapeutics 9/13/2022

    Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

  4. Extending The Lower Limits Of Quantification Of A Therapeutic Oligonucleotide Through Microflow LC-MS/MS 3/4/2022

    Here a solution is presented to widely recognized challenges with ionpairing reversed phase liquid chromatography (IP-RP LC) through a novel microflow LC-MS strategy.

  5. Ultra-Sensitive Assay For Anti-Sense Oligonucleotide Quantification 3/1/2022

    Learn about a new level in sensitivity for challenging analytes in matrix that opens doors for accurate bioanalysis and metabolism studies with specificity not achievable with orthogonal methods.

  6. The Execution Stage Of Technology Transfer 5/2/2024

    What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.

  7. mRNA Manufacturing Workflow: Get To Clinic And Market Faster

    Explore each intertwined step in the mRNA manufacturing process and how a flexible approach can get your mRNA product to clinic and market faster.

  8. Avoiding The Pitfalls Of LNPs And Complex Formulations

    Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

  9. Digital Solutions Advance Your mRNA Manufacturing Workflow 6/17/2024

    Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.

  10. Discussing mRNA: Challenges And Opportunities For Scale-Out And Optimization 2/6/2024

    In a recent Cell & Gene Live event, experts explored challenges surrounding raw materials – both quality and supply – as well as the importance of achieving more efficient scale-out and turnaround times for mRNA production.