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* All TheraPEAK® Products are produced according to applicable GMP standards and follow the USP/EP guidance for cell and gene therapy raw materials. It is the end user's responsibility to ensure full compliance with local regulations in terms gf safety assessments and effective removal prior to patient exposure. TheraPEAK® Media Products are produced at FDA registered manufacturing sites with an ISO 13485 certified quality management system. TheraPEAK® Nucleofector® Solutions are manufactured at a GMP certified site. TheraPEAK® Nucleofector® Cartridges and Reservoirs are produced at manufacturing sites with an ISO13485 certified quality management system. TheraPEAK® Nucleofector® Products are not intended for in vivo and/or diagnostic purposes.