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GMP T Cell Expansion Medium and Activators for T Cell Therapy Development and Manufacturing
T cell therapy is a rapidly progressing treatment option for cancer patients, however, many therapies fail during clinical trials due to issues with safety, efficacy, or regulatory roadblocks. These challenges make it difficult for cell therapy manufacturers to reach the commercialization stage, resulting in costly therapies that are unaffordable and inaccessible to many patients. By using products manufactured according to current Good Manufacturing Practices (cGMPs), scientists can avoid costly regulatory delays. Furthermore, by considering their full workflow and choosing products that are already optimized and highly compatible, cell therapy manufacturers can streamline their process development and save time while reducing costs.
Achieve robust and consistent T cell expansion and activation using GMP ܲԴǰܱ™-XF with GMP ܲԴǰܱ™ Human T Cell Activators CD3/CD28/CD2 and CD3/CD28. These reagents have been optimized for use in T cell therapy development and manufacturing, providing excellent T cell growth and viability without the use of magnetic beads, feeder cells, or antigens. The ܲԴǰܱ™ T cell workflow streamlines T cell therapy development by enabling process standardization and scale-up from discovery through to clinical and commercial manufacturing.
ܲԴǰܱ™-XF and ܲԴǰܱ™ Activators were designed for use as ancillary materials in cell and gene therapy manufacturing according to USP 1043 and ISO 20399 guidelines and manufactured under relevant cGMP regulations. Full quality and traceability documentation is available to support cell therapy developers' risk assessments and regulatory filings, including Certificates of Origin and Certificates of Analysis. US FDA Master Files are in progress for the ܲԴǰܱ™ product line and will be filed in 2024.
On this page, you will find tools and resources that support your T cell therapy development, our answers to some frequently asked questions, and a form where you can sign up to try GMP ܲԴǰܱ™-XF and ܲԴǰܱ™ T Cell Activators.
Why Use ܲԴǰܱ™ for T Cell Therapy Manufacturing?
- Expand T cells for use in cell therapy development with a medium produced under relevant cGMPs
- Reduce variability by expanding T cells in serum- and xeno-free culture conditions
- Achieve robust T cell expansion with high viability
- Obtain T cells able to produce cytokines upon restimulation
- Activate T cells bead-free by combining ܲԴǰܱ™-XF medium with ܲԴǰܱ™ Human T Cell Activators from preclinical development through to commercial manufacturing
Generate High Yields of Viable and Functional T Cells—See the Data
Enhance your cell therapy development by choosing the high-performance combination of GMP ܲԴǰܱ™-XF and GMP ܲԴǰܱ™ T Cell Activators. See the data for each activator below:
Figure 1. GMP ܲԴǰܱ™-XF and GMP ܲԴǰܱ™ Human CD3/CD28 T Cell Activator Generate High Yields of Viable and Functional T Cells
Negatively selected Pan T cells were isolated using EasySep™ Human T Cell Isolation Kit, activated and expanded using ܲԴǰܱ™ Human CD3/CD28 T Cell Activator", and supplemented with recombinant human interleukin-2 (rhIL-2). (A) Cumulative fold expansion and percentage viability shown over a 10-day culture period. On Day 0, 1 x 106 isolated human T cells were stimulated with 25 μL of ܲԴǰܱ™ Human CD3/CD28 T Cell Activator in ܲԴǰܱ™-XF in a final volume of 1 mL. Subsequent to activation on Day 0, no additional ܲԴǰܱ™ Human CD3/CD28 T Cell Activator was added during the 10-day culture period (mean ± SD in 3 experiments with 7 donors). (B) High CD25 expression on Day 3 of culture indicates robust T cell activation. (C) A clustered morphology is seen in activated human T cells after 3 days of culture.
Figure 2. GMP ܲԴǰܱ™-XF and GMP ܲԴǰܱ™ Human CD3/CD28/CD2 T Cell Activator Generate High Yields of Viable and Functional T Cells
Negatively selected Pan T cells were isolated using EasySep™ Human T Cell Isolation Kit, activated and expanded using ܲԴǰܱ™ Human CD3/CD28/CD2 T Cell Activator, and supplemented with recombinant human interleukin-2 (rhIL-2). (A) Cumulative fold expansion and percentage viability shown over a 10-day culture period. On Day 0, 1 x 106 isolated human T cells were stimulated with 25 μL of ܲԴǰܱ™ Human CD3/CD28/CD2 T Cell Activator in ܲԴǰܱ™-XF in a final volume of 1 mL. Subsequent to activation on Day 0, no additional ܲԴǰܱ™ Human CD3/CD28/CD2 T Cell Activator was added during the 10-day culture period (mean ± SD in 3 experiments with 7 donors). (B) High CD25 expression on Day 3 of culture indicates robust T cell activation. (C) A clustered morphology is seen in activated human T cells after 3 days of culture.
Try GMP ܲԴǰܱ™ Now
Are you interested in testing how your T cells perform in GMP ܲԴǰܱ™-XF with GMP ܲԴǰܱ™ Human T Cell Activators? Sign up below to have a sales representative contact you about an introductory offer to try ܲԴǰܱ™-XF Medium and Human T Cell Activators in your lab.
Advancing T Cell Therapies: Insights from the Translational T Cell Talks
On June 11, 2024, ϳԹ hosted the half-day virtual event “Translational T Cell Talks: Scaling for the Future” in collaboration with Scientist.com. The presentations from distinguished scientists and industry leaders, provided insights into the latest developments in translational T cell research and CAR T cell innovations, and concluded with a discussion on improving collaboration between industry and academia.
Frequently Asked Questions
What is GMP and why is it important for my research?
Products manufactured according to current Good Manufacturing Practices (cGMPs) helps facilitate ancillary material qualification and risk assessment by cell therapy developers streamlining regulatory reviews of regulatory filings with global authorities, such as the US Food and Drug Administration (FDA) or the European Medicines Agency in Europe (EMA).
All of ϳԹ’ GMP products have or will have Master Files available, which contain detailed information regarding product components and manufacturing processes. To learn more about our approach to quality and compliance, including GMP, explore the resources on our Quality Page. There you’ll also find information on the regulatory support we can provide to help you move your development from the bench to the clinic.
What does serum- and xeno-free mean for cell culture media?
ܲԴǰܱ™-XF is a serum- and xeno-free medium, which means that the finished product was not manufactured with any primary raw materials derived directly from non-human animals. Recombinant materials are generated with non-human animal DNA sequences, resulting in a product that does not contain any raw materials (serum, plasma, or hemolymph), but may contain other biological materials.
Interested in other solutions for your T cell therapy workflow? View more products here.
Additional Resources for T Cell Therapy Research and Development
