Cell and gene therapy (CGT) programs are rapidly advancing from research and development to clinical trials and commercial approval. Establishing a robust, repeatable, and sustainable process early on can help accelerate development and avoid manufacturing transfer-related delays.
Thermo Fisher Scientific has a long history of partnering with cell and gene therapy developers to help advance their therapies by providing innovative technologies, technical consultation, and services. We offer closed systems and single-use technologies (SUT) developed for cell and gene therapies and biologic development that offer the flexibility required to establish new processes while enabling standardization of processes at multiple scales. In addition to instrumentation and reagents, we offer expertise, services, and custom solutions to help you translate your cell therapy from discovery to clinical research and commercial manufacturing.
The value of single-use technology for cell and gene therapy
SUT provides robust solutions that reduce the risk of contamination. It is well understood that SUT shortens turnover time for equipment, which can help accelerate development. By establishing control platforms and replicable processes, cell and gene therapy developers can more efficiently scale up their solutions through clinical trials and commercial manufacturing.
Our BioProcess Containers (BPC) are flexible containment systems made from a catalog of proprietary polymer films. These films have been specifically designed to meet the needs of bioprocessing customers and are widely used in the bioprocessing industry. In addition, we offer a wide range of rigid, single-use consumables such as cell factory systems (for adherent cell culture), bottles, and fluid transfer assemblies.
As you scale your processes, we offer single-use equipment for adherent and suspension cell lines, including bioreactors and mixers from bench scale to production. These products meet specific cell and gene therapy needs, such as low shear cell processing.
The value of closed manufacturing solutions
In cell therapy, closed manufacturing systems are designed to minimize contamination risks and reduce ISO cleanroom requirements. In combination with digital connectivity, these systems enable repeatable, trackable, and GMP-compliant manufacturing processes.
For cell therapy manufacturing, we currently provide multiple closed systems with SUT consumables, including the Gibco CTS Rotea Counterflow Centrifugation System and the Thermo Scientific HyPerforma Rocker Bioreactor. The Rotea System is a closed and automated cell-processing system that provides process flexibility and enables cell separation, wash, concentration, and buffer exchange.
Gibco CTS Rotea Counterflow Centrifugation System
A compact, flexible closed cell processing system, designed to streamline and expedite your cell therapy development, that enables:
- Process flexibility—user-programmable software enables you to create and optimize a broad range of protocols for cell separation, washing, and concentration
- High cell recovery and viability—gentle processing enables >95% cell recovery while maintaining cell viability
- Low output volumes—proprietary technology can deliver as little as 5 mL of concentrate
- Research through commercial manufacturing—the closed single-use kit enables sterile processing, and an OPC-UA interface enables connectivity to a 21 CFR Part 11-compliant system
Gibco CTS Xenon Electroporation System
A closed, scalable electroporation system for GMP-compliant cell therapy manufacturing
- High speed and large volume—transfect up to 2.5 x 109 T cells/25 mL in less than 25 minutes
- Scalable, proven performance and viability—up to 90% gene knockout with CTS TrueCut Cas9 Protein and 80% cell viability
- Process flexibility—user-programmable system enables you to create and optimize electroporation protocols for various cell types and payloads, from process development through commercial manufacturing
- Efficient nonviral transfection—can be used to deliver DNA, RNA, and protein payloads
- Closed-system processing—Xenon MultiShot Electroporation Cartridge helps enable sterile welding to PVC or C-Flex™ tubing
Closed system-compatible media and reagents
Many of our CTS media and reagents designed for cell and gene therapy applications are available in a format designed to be used in your closed system workflow. Closed system-compatible media is provided in a BioProcess Container (BPC) designed with a variety of options suitable for aseptic integration into your workflow including sterile welding, MPC, Luer lock, and a septum port.
Control and data management
To control your process and manage your data, we offer the HyPerforma G3Lab Controller and the TruBio control system, based on the robust DeltaV platform, helping you to develop GMP-compliant processes as you eliminate costly and time-consuming tech transfers later in your process.
Whether you are establishing a new process or need to improve your existing one, contact us to discuss how we might be able to help.
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