MilliporeSigma Articles

71. 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.

72. 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.

73. 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.

     

74. 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.

75. Cell Based Potency Assay In Functional Characterization Of mAbs 6/12/2019

    Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

76. 4 Considerations For Overcoming Challenges In Gene Therapy Testing

    With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

77. The Importance Of Scalability In Viral Vectors

    Diseases that lack a cure, or even treatment, may be addressed with new gene therapeutic classes. This potential has spurred new investments in the drug development and commercialization space.

78. Data Utilization For Advanced Analytics And Near Real-Time Monitoring

    Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.

79. Robust Harvest Clarification For Adeno-Associated Viral Vectors

    This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.

80. Perspectives Of Value-Driven, Integrated Solutions In Gene Therapy

    With an integrated solutions provider, you can leverage a comprehensive suite of advanced technologies and expertise that will facilitate your path to market and benefit you for the lifetime of your product.