Advancing your cell therapy development workflow
Cell therapy is one of the most exciting and dynamic fields in modern medicine. Like you, we believe in the promise of cell therapies to cure what was once thought of as incurable. And, like you, we know that this begins with careful material selection and all the way from process development through clinical trials and commercial manufacturing. That is why our goal is to help you further your progress and support your journey to success.
What’s new: Gibco CTS DynaCellect Magnetic Separation System
The CTS DynaCellect Magnetic Separation System is a closed, automated isolation, activation, and bead removal system for cell therapy development and manufacturing. Together with fit-for-purpose consumables, it delivers high cell purity, recovery, and viability. As a standalone instrument or as part of a workflow, the operator-independent system can help you isolate the right cells and minimize failures in manufacturing while helping provide increased robustness and precision.
Click on the links to request a demo, request a quote, or take an interactive 3D tour of the CTS DynaCellect Magnetic Separation System.
For the most critically ill patients, time is truly of the essence, and even minor delays to treatment can have catastrophic consequences. This includes processing time, as it can directly impact the biology of the drug. Since a manufacturing system cannot provide the same conditions as a human body, minimizing the amount of time a cell is outside a body is vital.
Using automation in the manufacturing process is one method to help ensure T-cells spend little time ex vivo. The Gibco CTS DynaCellect Magnetic Separation System streamlines process development with rapid, closed, and fully automated cell isolation, activation, and Gibco CTS Dynabeads bead removal. With the CTS DynaCellect system and Gibco CTS Dynabeads CD3/CD28 beads, you can isolate cells in ~100 minutes, shorten bead removal time from ~5 hours to under 1 hour, reduce handling time, and improve process efficiency with fit-for-purpose kits.
Another technology that can help shorten cell therapy manufacturing, saving resources and time-to-patient, is Thermo Fisher’s next-generation Gibco CTS Detachable Dynabeads beads. With CTS Detachable Dynabeads beads, customers do not need to wait 5 days for passive dissociation. The Dynabeads can be actively released from cells at any time point.
Thermo Fisher Scientific has solutions to help you with your cell therapy manufacturing speed.
While there is always a need to scale-up from the initial R&D stages to clinical and commercial manufacturing, cell therapy has a unique challenge. Individualized autologous treatments are likely to be permanently manufactured in relatively small volumes. This may require the manufacturing process to be scaled out, or having multiple processes running in parallel, to meet increasing demand. On the other hand, scaling up is going to be essential for future allogeneic therapies—not only to enable initial cell expansion, but also to enable large-scale bioproduction with volumes entering the hundreds, if not thousands, of liters while maintaining efficacy and quality.
Central to achieving either scaling out or scaling up, is careful material selection. Choosing manual or automated instruments as well as selecting the right media can have an impact on the scalability of your process. Materials selected for the process need to have consistent performance at both the process development stage and during the scaled-up commercial stage.
Additionally, it is more important than ever for workflow components to be consistent in terms of both quality and supply. By offering innovative Gibco products and services backed by a robust global manufacturing network, Thermo Fisher Scientific can help you scale out or scale up your cell therapy manufacturing with confidence.
Thermo Fisher Scientific has solutions to help you with your cell therapy manufacturing scalability.
Whether scaling out or up, maintaining cell phenotype is critical. Research has shown that less differentiated cells—young naive (TN) cells that differentiate into central memory (TCM) cells and finally mature into T effector memory (TEM) and T effector (TEFF) cells—correlates with higher efficacy of T-cell therapies.
The point at which cells are collected after the isolation process as well as media used both have critical roles to play in maintaining cell phenotype. Actively releasing magnetic beads from cells can help you obtain naïve and early memory cell phenotypes by controlling the duration of activation. In addition, using a medium that shifts a cell’s metabolism in a certain way decreases effector differentiation and results in increased frequencies of CAR T-cells with a central memory cell phenotype.
Thermo Fisher Scientific has solutions to help you maintain cell phenotype in your cell therapy manufacturing.
For the most critically ill patients, time is truly of the essence, and even minor delays to treatment can have catastrophic consequences. This includes processing time, as it can directly impact the biology of the drug. Since a manufacturing system cannot provide the same conditions as a human body, minimizing the amount of time a cell is outside a body is vital.
Using automation in the manufacturing process is one method to help ensure T-cells spend little time ex vivo. The Gibco CTS DynaCellect Magnetic Separation System streamlines process development with rapid, closed, and fully automated cell isolation, activation, and Gibco CTS Dynabeads bead removal. With the CTS DynaCellect system and Gibco CTS Dynabeads CD3/CD28 beads, you can isolate cells in ~100 minutes, shorten bead removal time from ~5 hours to under 1 hour, reduce handling time, and improve process efficiency with fit-for-purpose kits.
Another technology that can help shorten cell therapy manufacturing, saving resources and time-to-patient, is Thermo Fisher’s next-generation Gibco CTS Detachable Dynabeads beads. With CTS Detachable Dynabeads beads, customers do not need to wait 5 days for passive dissociation. The Dynabeads can be actively released from cells at any time point.
Thermo Fisher Scientific has solutions to help you with your cell therapy manufacturing speed.
While there is always a need to scale-up from the initial R&D stages to clinical and commercial manufacturing, cell therapy has a unique challenge. Individualized autologous treatments are likely to be permanently manufactured in relatively small volumes. This may require the manufacturing process to be scaled out, or having multiple processes running in parallel, to meet increasing demand. On the other hand, scaling up is going to be essential for future allogeneic therapies—not only to enable initial cell expansion, but also to enable large-scale bioproduction with volumes entering the hundreds, if not thousands, of liters while maintaining efficacy and quality.
Central to achieving either scaling out or scaling up, is careful material selection. Choosing manual or automated instruments as well as selecting the right media can have an impact on the scalability of your process. Materials selected for the process need to have consistent performance at both the process development stage and during the scaled-up commercial stage.
Additionally, it is more important than ever for workflow components to be consistent in terms of both quality and supply. By offering innovative Gibco products and services backed by a robust global manufacturing network, Thermo Fisher Scientific can help you scale out or scale up your cell therapy manufacturing with confidence.
Thermo Fisher Scientific has solutions to help you with your cell therapy manufacturing scalability.
Whether scaling out or up, maintaining cell phenotype is critical. Research has shown that less differentiated cells—young naive (TN) cells that differentiate into central memory (TCM) cells and finally mature into T effector memory (TEM) and T effector (TEFF) cells—correlates with higher efficacy of T-cell therapies.
The point at which cells are collected after the isolation process as well as media used both have critical roles to play in maintaining cell phenotype. Actively releasing magnetic beads from cells can help you obtain naïve and early memory cell phenotypes by controlling the duration of activation. In addition, using a medium that shifts a cell’s metabolism in a certain way decreases effector differentiation and results in increased frequencies of CAR T-cells with a central memory cell phenotype.
Thermo Fisher Scientific has solutions to help you maintain cell phenotype in your cell therapy manufacturing.
Cell therapy media
Whether you’re developing an autologous or allogenic T cell therapy, Gibco CTS OpTmizer Serum-Free Medium (SFM) has been designed to help you scale-up to clinical and commercial manufacturing. Our media can help to minimize the risk of contamination and variability in your manufacturing process. Furthermore, our media products are provided with extensive traceability documentation, including FDA Drug Master Files and Regulatory Support Files.
T cell proliferation in healthy donors evaluated using Gibco CTS OpTmizer Pro SFM
Enhanced cell growth was observed when cultured in the presence of CTS OpTmizer Pro SFM. Cells from six healthy donors were expanded in CTS OpTmizer Pro SFM. Cells were assessed at day 17. Improved growth that became more pronounced over time was observed as indicated by an average increase of 187% compared to Gibco CTS OpTmizer SFM, no phenol red.
T cell expansion in static cell culture plates
T cells were cultured in CTS OpTmizer T Cell Expansion SFM, no phenol red, for 10 days in static cell culture plates. (A) Cell growth was measured over time and reported as fold expansion (error bars are the standard deviations of each data set). Phenotypic characterization was performed on day 10 to determine (B) the ratio of CD8+ cells to CD4+ cells and (C) the degree of differentiation, as measured by CD62L and CCR7 expression within the CD3+ population. These investigations employed basal medium from another supplier containing 5% hABs, as a benchmark. Data represent the mean of three experimental replicates.
Cell therapy media and tools
Cell therapy reagents
The first step in manufacturing an immunotherapy is to collect peripheral blood mononuclear cells (PBMCs) from a patient (autologous) or donor (allogeneic). The cells then need to be isolated from other mononuclear cells. Gibco CTS Dynabeads magnetic beads are a trusted technology for the isolation, activation, and/or expansion of T cells ex vivo. Whether working with polyclonal T cells, antigen-specific T cells, gene-modified T cells, regulatory T cells, or other T cell subtypes, CTS Dynabeads magnetic beads enable the recovery of T cells with properties comparable to in vivo–activated T cells.
Optimized activation signal expands Tregs with highsuppressive potential.
Magnetically isolated regulatory T cells were expanded three times with CTS Dynabeads Treg Xpander for 14 days. Expanded Tregs are highly suppressive.
Cell therapy equipment
DynaCellect Magnetic Separation System
Designed to be used with magnetic Dynabeads, the CTS DynaCellect Magnetic Separation System consists of an intuitive, programmable interface, integrated magnet-rocker, and fluidics panel that will help you achieve exceptional cell recovery, a wide range of reaction volumes, optimal efficiency, and a cell purity rate of greater than 95%, while maintaining cell viability.
Gibco CTS DynaMag Magnet
The CTS DynaMag Magnet is ideal for magnetic isolation in closed, sterile blood bags. It is scalable from 50 to 330 mL in static separations and >10 L in continuous flow separations following T-cell expansion protocols. Residual beads that escape initial magnetic capture are retained on a secondary magnet.
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Related resources
Application note: Innovating for the future: Accelerating the arrival of immuno-oncology 2.0
Application note: One-step isolation and activation of naive and early memory T cells with CTS Dynabeads CD3/CD28
Application note: Efficient-Pro Medium and Feeds improve productivity in CHO-K1, CHO-S, and DG44 cells
Data sheet:CTS DynaCellect Magnetic System
Infographic:CTS DynaCellect Magnetic System: Evolving the future of cell therapy manufacturing
Poster:Optimization of a Phenol Red-Free T Cell Expansion Medium to Improve Performance and Workflow Flexibility
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