TissueGen: Significant Facility Upgrades

TissueGen, Inc. has completed major facility upgrades, thus allowing it to manufacture and develop ELUTE fiber in an ISO Class 7 cleanroom environment. ELUTE fiber is a biodegradable fiber format for advanced drug delivery.

“ELUTE fiber revolutionizes how medical applications may be approached, enabling breakthroughs in advanced drug delivery, nerve regeneration and tissue engineering, ” said TissueGen CEO Christopher Knowles, in the December 15, 2015 news release. “We are dedicated to complying with the same rigorous quality standards to manufacture and develop ELUTE fiber that our pharmaceutical, therapeutic and medical device customers must meet for FDA approval.”

As indicated in the news release, “TissueGen’s biodegradable ELUTE fibers may replace standard fibers currently incorporated in fiber and medical textile applications and significantly improve clinical outcomes by delivering therapeutic agents directly at the surgical site. Through localized controlled release of drugs at the site of implantation, ELUTE fibers may enable medical devices to orchestrate the body’s healing and regenerative processes.”

Christopher Knowles told OTW, “The manufacturing upgrades included: installation of seven filter HEPA filtration system; LED cleanroom lighting; upgraded air supply system to an oil-less air compressor filtered system; installed electrostatic discharge flooring and work surfaces; cleanable flooring, ceiling, walls and work surfaces; certified ISO Class 8 ante room for entry to newly installed certified ISO Class 7 cleanroom manufacturing and development facility. Phase II of facility upgrades (pending) will include supplementing air conditioning, dehumidification, and ventilation systems.”