Miltenyi Biotec introduces world’s first operator-free GMP-compliant cell sorting system

With its new MACS^® GMP Tyto^® Cartridge, Miltenyi Biotec opens new possibilities for fluorescence-based, GMP-compliant cell sorting – a significant step forward for translational research and medical applications. Specifically developed for the MACSQuant^® Tyto^® Cell Sorter, the launch of the cartridge makes Miltenyi Biotec the first company ever to offer GMP-compliant multiparametric, fluorescence-based cell sorting under safe and sterile conditions.

Forming the heart of the cell sorting system, the MACS GMP Tyto Cartridge is already being put to use in the first human iPS trial of Parkinson’s disease, currently taking place at CiRA, Kyoto, where iPS cells were first discovered just 12 years ago.

“When using a conventional droplet-based system, we were manually exchanging sorting vials every 10 minutes for 16 hours straight; that’s just not practicable for a viable treatment,” explains Dr. Doi, Assistant Professor in CIRA`s clinical trial program headed by Jun Takahashi. “Using the MACS GMP Tyto Cartridge with the MACSQuant Tyto Cell Sorter, we’re able to cut cell production time by a third and increase yields. In other words, we’re able to get more product to patients’ bedsides more quickly.”

“We’re proud to offer the only GMP-compliant solution for multiparametric, high-speed cell sorting,” states Dr. Bastian Ackermann, Marketing Manager at Miltenyi Biotec. “Not only does it eliminate safety concerns connected with conventional droplet-based systems in clinical settings, it will help great minds do great things.”

Providing comprehensive documentation to address regulatory requirements

To help researchers meet the requirements of regulatory authorities for cell manufacturing protocols, every MACS GMP Tyto Cartridge comes with a batch-specific certificate of analysis (CoA), a TSE risk statement, and a product information file (PIF). PIFs, provided for all MACS GMP Products, have proven very useful in the discussions with regulatory authorities, as they give detailed information on raw materials, QC release testing, sterility testing, biocompatibility, endotoxin levels, packaging, transport, and shelf life.

The sorting principle

The MACSQuant TytoCell Sorter with its patented microchip-based technology allows for high-speed, multiparameter cell sorting in a fully closed system. Cells remain inside the closed cartridge at all times during the sorting process, and no sheath fluid is present in the system. Miltenyi Biotec’s range of MACS GMP Fluorescent Antibodies and MACS GMP Tyto Running Buffer complement the system to make sure that cells only come in contact with GMP-compliant products.

Due to the closed design of the cartridge, cell sorting using the MACSQuant Tyto Cell Sorter provides full operator and sample safety. The easy “plug-and-play” format of the instrument, combined with automated cartridge alignment and operator-free sorting, makes cell sorting accessible to any lab professional, without intensive training.

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