Thermo Fisher Accelerates Cell Therapy Manufacturing With Next-Generation Platform of Detachable Dynabeads
Thermo Fisher Scientific Inc.'s Gibco CTS Detachable Dynabeads is a next-generation platform of Dynabeads that offers the first active release mechanism of its kind for clinical trial and commercial manufacturing use.
The active release mechanism uses a release buffer that lets users actively detach Dynabeads from a target cell at any point during the 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 users 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.
Other process improvements include:
- Increased control over target cell isolation and bead removal steps to help you shorten the timing of your overall process
- Increased control over cell activation and persistence of activation signals post-isolation
- High levels of pure T cells free from ancillary material
- Optimal recovery of target cells
- Desired cell phenotypes for downstream gene modification and fold expansion
- Suitable applications for both autologous and allogeneic processes
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 serves both autologous and allogeneic manufacturing processes across multiple cell modalities.
Thermo Fisher’s portfolio is manufactured according to cGMP, designed to meet cell therapy standards, and includes traceability and regulatory documentation to help customers transition from research to clinical trials and commercial production.
Thermo Fisher Scientific Inc. delivers a combination of innovative technologies, purchasing convenience, and pharmaceutical services through its brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. For more information, please visit www.thermofisher.com.
