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GEN News Highlights : Mar 5, 2010

Xcellerex to Develop Single-Use Manufacturing Technology for Humacyte’s Vascular Grafts

Xcellerex will leverage its XDR bioreactors and FlexFactory platform to allow future scale-up.

Xcellerex and Humacyte signed a collaboration agreement under which Xcellerex will develop a single-use manufacturing process for Humacyte’slarge-diameter vascular graft product. The graft will initially be manufactured for use by Humacyte in ongoing preclinical development.

The graft utilizes Humacyte’s extracellular matrix-based tissue technology. It is in development initially for arterio-venous access in patients on hemodialysis. The company hopes it will eventually be used as a replacement for diseased or damaged blood vessels.

Humacyte developed the technology for cultivating vascular grafts using small-scale bioreactors that generate one graft at a time. The company will provide the collaboration with cell-biology and vascular-graft technology and know-how. Working together, the firms aim to transform the small-scale process into a more robust process for the commercial supply of multiple vascular grafts.

The manufacturing process to be developed will exploit Xcellerex’ XDR single-use bioreactor system in its FlexFactory® platform. The companies have been collaborating on design work for the process.

The FlexFactory line will be assembled, tested, and operated at Xcellerex for protocol development and proof-of-concept graft production. The company says that it may also complete engineering and/or GMP manufacturing runs for Humacyte before transferring the modular FlexFactory line to Humacyte’s facility.

“Our exciting collaboration with Xcellerex will both advance our novel vascular graft for transplantation technologies but also enable us to move more rapidly into clinical development upon the achievement of key development and preclinical milestones,” states Laura Nilason, Humacyte’s founder.

Humacyte’s core technology is the engineering of human-based tissue scaffolds that can be shaped into tubes, sheets, or particulate conformations and can be applied to many specific applications. The company says that it uses a unique cell source to grow the scaffolds.

The single-use XDR bioreactor system is at the heart of Xcellerex’ FlexFactory bioprocess manufacturing platform. The company claims that because the platform is built almost exclusively around disposable technology, each unit operation is self-contained in its own controlled environment module (CEM), which eliminates the need for expensive clean-room facilities. XDR systems are available with working volumes of 50, 200, 500, 1,000, and 2,000 liters.