MilliporeSigma Articles

  1. The Role Of Extractables Data In The Adoption Of Single-Use Systems 8/29/2024

    Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.

  2. Business Continuity Management: The Benzonase® Endonuclease Success Story 8/21/2024

    Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.

  3. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  4. Scaling Up The Learning Curve For Large-Scale AAV Manufacturing 7/26/2024

    The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.

  5. Technology Transfer Considerations 6/13/2024

    Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.

  6. Process Validation Considerations 6/13/2024

    Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach.

  7. Optimizing mRNA For Success: A Guide To Enhanced Stability, Delivery, And Efficacy 6/11/2024

    RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.

  8. The Next Generation Of mRNA Products: Implications For Quality Control 5/30/2024

    To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.

  9. Benefits Of PCR-Based mRNA Manufacturing Processes 5/17/2024

    Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.

  10. Strategies For Ensuring Virus Bank Manufacturing Success 4/29/2024

    Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.