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TissueGen upgrades to ISO Class 7 facility for Elute fibre

17 Dec '15

2 min read

TissueGen Inc., developer of Elute fibre, a groundbreaking biodegradable fibre format for advanced drug delivery, has upgraded its significant facility upgrades now enabling TissueGen to manufacture and develop Elute fibre in an ISO Class 7 cleanroom environment to support the Food and Drug Administration's cGMP regulations for manufacturing drug product.

The company has implemented an ISO 13485:2003 quality management system to ensure quality controls and installed robust HEPA filtration systems to adhere to stringent air quality requirements. This now enables all development and manufacturing of Elute fibres to be performed in compliance with the same rigorous FDA standards as those applied to pharmaceutical and device manufacturers, according to a press release.

TissueGen's biodegradable Elute fibres may replace standard fibres currently incorporated in fibre and medical textile applications and significantly improve clinical outcomes by delivering therapeutic agents directly at the surgical site. Through localised controlled release of drugs at the site of implantation, Elute fibres may enable medical devices to orchestrate the body's healing and regenerative processes.

Christopher Knowles, CEO, TissueGen said, “Elute fibre revolutionises how medical applications may be approached, enabling breakthroughs in advanced drug delivery, nerve regeneration and tissue engineering. We are dedicated to complying with the same rigorous quality standards to manufacture and develop Elute fibre that our pharmaceutical, therapeutic and medical device customers must meet for FDA approval.” (GK)

Fibre2fashion News Desk - India