For the approval of your cell manufacturing process, all components of your workflow need to meet regulatory requirements. With the MACSQuant® Tyto® Cell Sorter, Miltenyi Biotec offers sterile and GMP-compliant multiparametric cell sorting in a closed cartridge system. Our MACS® GMP Tyto Consumables are specifically developed for GMP-compliant cell sorting, facilitating translation into clinical research settings.
For regulatory approval of your cell manufacturing protocols, we are providing certificates of analysis (CoA), certificates of origin (CoO), and product information files (PIF). These documents are available for all individual consumables, including the MACS GMP Tyto Running Buffer (composed of MACS GMP PBS/MgCl2 Buffer and MACS GMP Tytonase), the MACS GMP Tyto Cartridge, and MACS GMP Fluorescent Antibodies.
PIFs have been proven very useful in discussions with regulatory authorities and were used by several customers for approval of clinical trials. They provide detailed information on, e.g., in-process controls, QC release testing, sterility testing, biocompatibility, endotoxin levels, particles, packaging, transport, and shelf life stability.
For complete regulatory notes click here.