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Miltenyi Biotec distribution:
As a global market leader with numerous subsidiaries and distributors, Miltenyi Biotec is committed to providing our customers around the world with the highest quality products. In addition to direct selling in more than 20 countries in North America, Europe and Asia/Pacific, Miltenyi Biotec also provides support for our customers through an extensive distributor network covering dozens of additional countries.
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.