MACS® GMP Tyto® Consumables

GMP-compliant cell sorting in clinical settings

  • Optimized for use with the MACSQuant® Tyto® Cell Sorter
  • In compliance with relevant GMP guidelines
  • Comprehensive documentation available, including CoA, CoO, and PIF

For the approval of your cell manufacturing process, all components of your workflow need to meet regulatory requirements. 

To help meet these requirements, Miltenyi Biotec now offers sterile, GMP-compliant multiparametric cell sorting in a fully closed system. The sort process on the MACSQuant Tyto Cell Sorter happens exclusively within the MACSQuant Tyto Cartridge. Inside this closed system, cells are protected from environmental contamination and remain sterile. Our MACS® GMP Tyto Consumables were specifically developed for GMP-compliant cell sorting, facilitating translation into clinical settings. 

In order to enable you to get regulatory approval of your cell manufacturing protocols, we provide you with 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.

The PIF, as it is provided for all of Miltenyi Biotec´s MACS GMP Products, has proven very useful in the discussions with regulatory authorities. It provides 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 notices click here.

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Miltenyi Biotec Inc.
phone: +1 800 FOR MACS
fax: +1 530 745 2806
macs@miltenyibiotec.com