If there are LULL restrictions, an assessment of your intended use may be required.
#Texmacs gmp medium license#
Researchers are free to use these products in accordance with the Limited Use Label License (LULL) for early research-based clinical trials through Phase IIA. CTS products are intended for use as ancillary reagents used in the manufacturing process which includes a wash step prior to any in vivo application.Ĭan I use CTS products in clinical trials? CTS products cannot be used for direct in vivo applications. In all cases, it is the researcher’s responsibility to get approval from the appropriate regulatory authorities for labeling and intended use of these ancillary materials for your application beyond phase IIA trials.Ĭan I use CTS products for in vivo clinical use? Commercial access to these products may be available through a formal Supply Agreement under which we do not anticipate that there will be any additional licensing fees for these products. Researchers are free to use these products in accordance with the Limited Use Label License (LULL), but commercial use is not allowed under general purchase of these products. However, the proper regulatory approval is required before using CTS products in research-based clinical trials since they may require specific labeling and/or higher quality manufacturing standards.Ĭan I use CTS Growth Factors/Cytokines for commercial use? CTS products are intended for use as ancillary reagents used in the manufacturing process which includes a wash step prior to any in vivo application.Ĭan I use CTS Growth Factors/Cytokines in clinical trials? CTS Growth Factors/Cytokines cannot be used for direct in vivo applications.
The result is a larger population of central memory cells in a shorter period of time.
#Texmacs gmp medium pro#
CTS OpTmizer Pro SFM improves central memory phenotype and cell growth by shifting the cell’s metabolism. Gibco CTS OpTmizer Pro SFM is a novel medium, developed for the growth and expansion of human T lymphocytes (e.g., CD4+, CD8+, polyclonal cells, or antigen specific T-cells) used in allogeneic cell therapies. Improve central memory phenotype and cell growth for allogeneic T-cell therapies. If you’re interested in a custom CTS product, please send us an inquiry. Learn more about the latest featured member of the product family - CTS OpTmizer Pro Serum Free Medium (SFM)įor more information about our product offerings, ordering information, and customer support, access our Cell Therapy Solutions brochure. The methods and controls used for ancillary material manufacturing conform with cGMP for medical devices, 21 CFR Part 820 and USP, Ph Eur 5.2.12. CTS products aim to reduce the time you spend from your initial discovery to approved therapy. Ongoing efforts in innovation allow us to offer media specific for the growth and expansion of human T-lymphocytes, for example, CTS OpTmizer Pro Serum Free Medium (SFM) for use in allogeneic cell therapies. We offer tailored T-cell media, dendritic cell culture media, and supplements for a variety of immune cell types. Our CTS T-cell culture media and reagents help minimize the risk of contamination and variability in your research and provide extensive traceability documentation, including FDA Drug Master Files and/or Regulatory Support Files to support regulatory review, thus facilitating a seamless transition from research to commercialization. Products for a smoother transition from research to clinic Whether you’re developing a CAR-T therapy, another type of T-cell immunotherapy, or working with other immune cell types, Gibco CTS products are the superior choice from research to clinic, and beyond.Ĭell Therapy Systems (CTS) tools, reagents, and services, support cell therapy research and further manufacturing of cell-, gene-, and tissue-based products.
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