Description
Background information
Polyclonal T cell expansion can be used in applications of cellular therapy when increased numbers of effector cells are required or when T cells are activated to improve gene modification.
MACS® GMP T Cell TransAct™ CR/GMP consists of a colloidal polymeric nanomatrix covalently attached to humanized recombinant agonists against human CD3 and CD28.
Due to the nanomatrix MACS GMP T Cell TransAct™ CR/GMP can be sterile filtered and excess reagent can be removed by centrifugation and following conventional supernatant replacement or simply by medium wash. This reagent is suitable for the use in automated culture systems, such as the CliniMACS Prodigy® Instrument.
MACS® GMP T Cell TransAct™ CR/GMP: The reagent is optimized to activate and expand 1×108 enriched T cells.
MACS® GMP T Cell TransAct™ CR/GMP - Large Scale: The reagent is optimized to activate and expand up to 4×108 enriched T cells.
Applications
MACS® GMP T Cell TransActTM CR/GMP is intended for the in vitro stimulation and expansion of human T cells from hematological cell populations (e.g. PBMC or enriched T cells).
Quality statement
MACS GMP Products are manufactured and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials.
Disclaimer
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
Disclaimer
MACS GMP Products are for ex vivo cell processing only, and are not intended for human in vivo applications. For regulatory status in the USA, please contact your local representative.
Overview
MACS®GMP T Cell TransAct™ CR/GMP for T cell activation via CD3 CD28 in clinical research. Suited for cell manufacturing according to GMP guidelines, the MACS® GMP Grade reagent is intended for in vitro stimulation and expansion of human T cells. It is optimized for automated cell culture such as CAR T cell manufacturing on the CliniMACS Prodigy®.
