07 September 2023 | Thursday | News
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Thermo Fisher Scientific Inc., the world leader in serving science, today announced the Gibco CTS Detachable Dynabeads (CTS Detachable Dynabeads)*, its next-generation platform of Dynabeads with the first active release mechanism of its kind for clinical trial and commercial manufacturing use.
The active release mechanism of CTS Detachable Dynabeads utilizes a release buffer that helps enable users to actively detach Dynabeads from a target cell at any point during their manufacturing process. As a result, CTS Detachable Dynabeads help drive manufacturing cost savings while delivering high cell purity, yield and viability. These manufacturing benefits can help cell therapy developers get more life-changing treatments to patients faster, especially for those diagnosed with complex diseases such as blood cancers.
CTS Detachable Dynabeads offer process flexibility, compatibility with automation, and scalability through its differentiating active release mechanism. This functionality, for cGMP and clinical use, helps empower users to achieve greater control of their process with the ability to consistently deliver target cells with the desired characteristics for their therapy. Cell recovery, phenotype, and viability for downstream steps within the workflow are also optimized through this platform. These advantages are critical for cell therapy manufacturers who need to scale their manufacturing while maintaining consistent performance as they transition from process development to clinical trials and commercial manufacturing.
The CTS Detachable Dynabeads platform works within Thermo Fisher Scientific’s modular, closed and automated cell therapy manufacturing workflow. In combination with Thermo Fisher Scientific’s Gibco Cell Therapy Systems (CTS) portfolio of products, including the Gibco CTS DynaCellect™ Magnetic Separation System, CTS Detachable Dynabeads allow users to shorten their manufacturing workflow by decreasing the time for steps downstream of cell isolation.
“Currently, cell therapies are seen as a last resort for patients in late stages of disease, but we’re committed to helping our customers realize its potential as a first-line treatment,” said Tiffani Manolis, vice president and general manager, cell culture and cell therapy, Thermo Fisher Scientific. “Our CTS Detachable Dynabeads platform represents a new generation of cell therapy isolation and activation products that prioritize patient quality and safety while also creating greater workflow control for our customers. These advancements are one step in the process of helping our customers commercialize affordable therapies faster and potentially save more lives.”
The first offering within this platform is the CTS™ Detachable Dynabeads™ CD3/CD28 Kit designed specifically to help manufacturers isolate and actively target T cells in a one-step mechanism. The CTS Detachable Dynabeads CD3/CD28 Kit of isolation and activation reagents will serve both autologous and allogeneic manufacturing processes across multiple cell modalities. The CTS Detachable Dynabeads CD3/CD28 kit is available for purchase now.
Thermo Fisher’s CTS portfolio of products are manufactured according to cGMP, designed to meet applicable cell therapy standards, and include traceability and regulatory documentation to help customers transition from research to clinical trials and commercial production.