SOURCE: TissueGen(R) Inc.

TissueGen(R) Inc.

December 15, 2015 12:00 ET

TissueGen's New ISO Class 7 Facility Supports FDA cGMP Drug Product Manufacturing

ELUTE® Fiber Now Manufactured and Developed in ISO Class 7 Cleanroom Facility

DALLAS, TX--(Marketwired - Dec 15, 2015) - TissueGen® Inc., developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, today announced the completion of significant facility upgrades now enabling TissueGen to manufacture and develop ELUTE fiber in an ISO Class 7 cleanroom environment to support the Food and Drug Administration's cGMP regulations for manufacturing drug product.

Also, TissueGen 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 fibers to be performed in compliance with the same rigorous FDA standards as those applied to pharmaceutical and device manufacturers.

"ELUTE fiber revolutionizes how medical applications may be approached, enabling breakthroughs in advanced drug delivery, nerve regeneration and tissue engineering," said Christopher Knowles, CEO, TissueGen. "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."

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. 

About TissueGen

TissueGen® Inc. is the developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, nerve regeneration, and tissue engineering. TissueGen has more than four decades of cumulative experience in extruding biodegradable polymer fibers with broad drug delivery capabilities. ELUTE fiber can directly replace standard fibers used in biodegradable textiles currently on the market and provide significantly improved clinical outcomes by delivering therapeutic agents directly at the site of the implant. By delivering drugs and growth factors at the site of implantation, ELUTE fiber enables medical devices to guide the body's healing and regenerative processes. For more information, please visit www.tissuegen.com.

Contact Information

  • For more information contact:
    Jordan Bouclin
    SVM Public Relations
    401-490-9700
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