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| MACS® GMP Products |
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The state-of-the-art development of clinical applications for cellular therapies is highly demanding in terms of quality, safety and sustainability, as defined by Good Manufacturing Practice (GMP) specifications.
Designed and produced in accordance to GMP standards, MACS® GMP Products optimally combine high quality with excellent performance and maximal safety. These new tools provide integrated solutions for cell separation and cell culture from one supplier.
The MACS GMP Products include:
• MACS GMP Antigens, as recombinant protein or peptide pool (PepTivator™), for efficient in vitro stimulation and subsequent isolation of viable antigen-specific CD4+ and CD8+ T cells using e.g. the CliniMACS Cytokine Capture System (IFN-gamma).
• MACS GMP Cytokines: FGF-2, GM-CSF, IL-1β, IL-2, IL-3, IL-4, IL-6, IL-7, TNF-α, IL-15 (coming soon) and IL-21 (coming soon)
• MACS GMP Cell Culture Media, for standardized and reproducible cell cultivation and ex vivo differentiation procedures
MACS GMP Products may be used for research or ex vivo cell culture processing. They are manufactured and tested under a certified ISO 9001 quality system and in compliance with relevant GMP guidelines. MACS GMP Products are designed following the recommendations of USP <1043> on ancillary materials. They are human- and animal-derived component free.
Cell Differentiation Bags and Cell Expansion Bags intended for in vitro cultivation, differentiation or expansion of human cells in functionally closed systems are CE-marked medical devices.
The MACS GMP Product range will continuously expand; more antigens, cytokines, cell culture media, and cell culture bags will be available in consistent GMP quality. |
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