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Cell therapy development depends on consistent, scalable processes that maintain quality from early research through commercial manufacturing. cGMP-ready bioprocessing solutions link collection, processing, and testing within connected, data-informed workflows. Using modular systems, defined reagents, and automation tools, Thermo Fisher Scientific helps enable teams to enhance productivity by simplifying manufacturing, reducing variability, and protecting cell integrity. With established materials and dedicated global support, we collaborate with customers to strengthen process reliability and move therapies toward the clinic with confidence.
Manual and disconnected steps can introduce variability, slowing progress and complicating scale-up. Our automation-ready systems connect cell therapy processes, improving reproducibility and efficiency across research and manufacturing. Integrated digital control and closed processing capabilities support data integrity, regulatory readiness, and consistent cell quality throughout development.
Different cell therapies demand highly tailored process conditions. Our flexible, modular solutions are engineered to adapt to chimeric antigen receptor (CAR) T-cells, natural killer (NK) cells, and stem cells. These solutions enhance productivity and advance reliability in cell therapy bioprocessing.
Scaling cell therapy manufacturing can increase complexity and risk to quality and cost control. cGMP-manufactured materials, single-use technologies, and regulatory documentation support predictable, compliant scale-up. These solutions enable teams to maintain process consistency from development to commercial production.
Cell therapy bioprocessing solutions are integrated systems, reagents, and digital tools designed to support the development and manufacture of cell-based therapies. These solutions include cell culture media, supplements, bioreactors, automated systems, and quality control methods that help enable consistent growth, modification, and preservation of therapeutic cells. They support productivity by helping to maintain cell viability, functionality, and safety throughout the production process, facilitating the reliable delivery of effective cell therapies.
Maintaining consistency when scaling cell therapy processes is challenging due to variability, especially with open or manual methods. Closed and automated systems, like the Gibco CTS Rotea Counterflow Centrifugation System and DynaCellect, enhance control and reproducibility. These systems support consistent processing and scalability across manufacturing stages, from process development to commercial production.
Stable T-cell growth and phenotype can be supported using defined media, supplements, and activation tools. OpTmizer One SFM and Immune Cell Serum Replacement enable consistent, serum-free culture conditions. Together with Gibco CTS DynaMag magnets and Gibco CTS Dynabeads magnetic beads, these solutions maintain early-memory T-cell phenotypes while reducing dependence on human serum in manufacturing processes.
Analytical assays such as flow cytometry and quantitative PCR are used to confirm cell identity and purity. PCR-based sterility and mycoplasma assays offer faster results than traditional culture-based methods, shortening turnaround times while supporting regulatory compliance. The combination of methods offers insights into cell characterization and product quality before release.
Managing costs during scale-up requires minimizing manual steps and variability. Standardizing consumables and integrating automated systems can help reduce material waste and labor demands. Single-use technologies further support cost control by simplifying changeover and cleaning requirements, enabling predictable, scalable production across different manufacturing phases.
During process development, Thermo Fisher Scientific offers access to regulatory documentation such as Certificates of Analysis (COAs), data sheets, and technical files. Teams can also work with technical specialists for guidance on workflow setup, documentation, and process transfer to help maintain consistency and compliance across development stages.
For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.