RNA Manufacturing Resources

  1. 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.

  2. 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.

  3. Data Processing For Mass Confirmation, Impurities Analysis Of Oligos 5/5/2022

    Explore an automated, compliance-ready LC-MS workflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including siRNA and large single guide RNA oligonucleotides.

  4. Genetic Engineering Medium Aiding The Transfection Of MSCs With siRNA 8/10/2023

    A newly developed genetic engineering medium is fueling the development of cell- and extracellular vesicle-based therapies.

  5. Bio4C ProcessPad™ 21 CFR Part 11 Compliance 1/12/2021

    Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

  6. Drug Discovery And Screening, A Digital Era For RNA-LNP Therapeutics 11/21/2022

    Learn about the key stages of drug discovery and screening as well as how to overcome bottlenecks in screening mRNA-LNPs to rapidly develop genomic medicines.

  7. Developing Robust mRNA Processes In A cGMP Environment 2/17/2023

    Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

  8. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 1/2/2024

    The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.

  9. Large Scale Purification Of Oligonucleotides With IEX 12/6/2024

    As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.

  10. Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA 11/1/2022

    Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.