MilliporeSigma Articles
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Anticipating The Next Decade Of Gene Therapy
The next decade will bring improvements including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.
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Viral Clearance Considerations For Adeno-Associated Virus (AAV) Vectors
There is no one-size-fits-all model for AAV gene therapy products when it comes to viral clearance studies. Here we address some of the questions with respect to viral clearance studies for AAV vectors.