MilliporeSigma Articles

  1. Navigating The Regulatory Maze: Fundamentals For Drug Development 7/15/2022

    Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey. 

  2. Remote Access And Monitoring Of Bioprocess Unit Operations 5/26/2022

    Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.

  3. Utilizing Multiple Tech Providers In Gene Therapy Manufacturing 5/19/2022

    With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.

  4. Trends In The Outsourcing Of Development And Manufacturing Of Biologics 3/18/2022

    Read more on trends related to outsourcing and share what attributes of an outsourcing partner are sought by developers and manufacturers of biopharmaceuticals.

  5. Development Of A Novel Sf9 Rhabdovirus-Negative Cell Line (Sf-RVN®) And Companion Chemically Defined Medium 3/15/2022

    This whitepaper describes the development of a novel Sf-RVN® cell line, with companion chemically defined medium, the EXCELL® CD Insect Cell Medium which can be combined and offer a Sf-Rhabdovirus free alternative for the BICS production of biologics.

  6. A Multifaceted Strategy For Viral Safety In AAV Processes 3/10/2022

    Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

  7. Regulatory Considerations For Alternative Microbial Methods 2/28/2022

    We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

  8. The Impact Of Facility Design On The Safety Of Viral Vectors 2/18/2022

    It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.

  9. Envisioning The Future Of Analytical Development For Gene Therapies 10/13/2021

    Explore how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.

  10. Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing 10/12/2021

    Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.