MilliporeSigma Articles

51. 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.

52. 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.

53. 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.

54. 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.

55. 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.

56. Downstream Process Intensification For Virus Purification 9/9/2020

    An overview of the challenges presented by current approaches to virus production and a platform approach that can work across different viral modalities and accelerate process development.

57. The Race From Lab To Clinic: 5 Critical Steps To Success 6/17/2020

    While the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. These five steps are key to putting your molecule on the right path.

58. Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus 6/17/2020

    In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.

59. Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies 5/15/2020

    A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of remarkable therapeutics.

60. Reducing The Risk During Cell And Gene Therapy Development And Manufacturing 5/13/2020

    While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.