MilliporeSigma Articles

61. 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.

62. Further Adapting New Bioprocess Technology In An Era Of Change 5/8/2020

    Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.

63. The Future Of MilliporeSigma's Gene Therapy CDMO Through The Lens Of History 4/27/2020

    On the road to becoming a global industry leader in cell and gene therapy, our viral vector manufacturing organization has undergone a major transformation over the last two decades. Marc Gaal, Director of Program Management at MilliporeSigma, details the history of the business as well as some of the milestones achieved since its inception.

64. Alternatives To In Vivo Assays For The Biosafety Testing Of Biologics 3/31/2020

    Even though alternative methods have emerged, in vivo tests have stubbornly remained a central part of biosafety testing. Here, we examine current in vivo methods and explore modern alternatives.

65. Process Monitoring, Data Management For Bioprocess Challenges 2/4/2020

    Setting up systems to automatically compile and analyze data routinely, versus compiling it, reduces workloads, provides timely access to critical information, and allows for data-driven decisions.

66. Droplet Digital Polymerase Chain Reaction 1/15/2020

    Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

67. Accelerating The Time To Market Of Gene Therapies Through Use Of A Platform Approach To Characterization And Safety Testing 11/14/2019

    As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Using adeno-associated virus (AAV) as one example, this white paper will describe how the implementation of platform characterization and safety assays for gene therapy vectors can increase the likelihood of success in process validation and accelerate the timeline to commercialization for gene therapy products and delivery to patients in need.

68. Avoid Costly Mistakes In Gene Therapy Process Development 11/14/2019

    Success in the gene therapy space requires navigating uncertainties related to the process development and manufacturing of AAV and lentivirus vectors. Use these tips when operating within short timelines.

69. Considerations For Upstream Biologic Development 11/12/2019

     

    A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

     

70. Rapid Sterility Testing: Viral And Gene Therapy Applications 10/29/2019

    For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.