New GMP-manufactured Cas9 Protein Enables Clinical Genome Editing Research

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The new GMP-manufactured Gibco CTS TrueCut Cas9 Protein from Thermo Fisher Scientific supports use of genome editing for research and manufacturing applications, including CAR T-cell therapy research. (Photo: Business Wire)

CARLSBAD, Calif.–  As researchers using genome editing tools move from basic research to clinical settings, high-quality ancillary materials and documentation are critical. To help researchers meet stringent quality requirements, Thermo Fisher Scientific introduced the new GMP-manufactured Gibco CTS TrueCut Cas9 Protein. TrueCut Cas9 proteins are manufactured with United States Pharmacopeia standards in mind, including traceability documentation, aseptic manufacturing and safety testing.

Gibco CTS TrueCut Cas9 Protein provides consistent high-editing efficiency in all tested cell lines and greater than 90% efficiency in human primary T-cells, making it a compelling solution for CAR T-cell therapy research using CRISPR-Cas9 genome editing. With the addition of a GMP-manufactured Cas9 protein and the recently launched Gibco CTS Xenon Electroporation System, Thermo Fisher can now support researchers across the autologous T-cell workflow.

“As genome editing quality and regulatory requirements continue to evolve, we are focused on providing solutions to meet scientists’ needs as they transition from the bench to the clinic,” said Brandon Pence, vice president and general manager of cell biology at Thermo Fisher Scientific. “By adding the Gibco CTS TrueCut Cas9 Protein to our portfolio of genome editing solutions, we can now support scientists in their journey to develop personalized CAR T-cell therapeutics.”

The Gibco CTS TrueCut Cas9 Protein is part of Thermo Fisher’s Cell Therapy Systems (CTS) product line, a comprehensive portfolio of GMP-manufactured products supported by traceability documentation. This product line is designed to work synergistically across the entire workflow, from cell isolation/activation to cell engineering and expansion, to address cell therapy developers’ manufacturing needs.