MilliporeSigma Articles

51. 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.

52. 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.

53. Designing Successful Viral Clearance Studies 12/23/2021

    Review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

54. 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.

55. 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.

56. Addressing The Challenge Of Scalability In Viral Vectors 8/10/2021

    Learn about a range of solutions developed to simplify the delivery of gene therapies to patients and address the challenges related to viral vector production and scale-up.

57. Optimized Cell Culture Medium For Scalable Viral Vector Production 7/20/2021

    Discover a cell culture medium that provides a superior alternative to traditional formulations and can help to overcome challenges in viral vector production and scale-up.

58. Beyond 2020: Looking Into The Crystal Ball For Gene Therapy 3/25/2021

    Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next.

59. 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.

60. Considerations For Bioreactor Process Development And Scale-Up For Transient Transfection-Based Lentivirus Production In Suspension 9/14/2020

    Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.