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Tissuegen awarded ISO 13485:2003 certification

31 Mar '16

2 min read

Tissuegen, a developer of Elute fibre, which is a bioresorbable fibre format for advanced drug delivery, nerve regeneration, and tissue engineering, has been awarded ISO 13485:2003 certification.

As per a Tissuegen press release, this follows from a significant investment in its quality management system and upgrades to its research, development and production infrastructure.

2015 was also marked by its strongest annual revenue to-date and significant personnel growth and was also the year in which, Tissuegen moved Elute fibre development and manufacturing to an ISO Class 7 cleanroom facility.

“Elute fibre is now developed and manufactured to support compliance with FDA cGMP requirements for manufacturing drug product,” the US based company said.

To drive continued growth for Elute fibre applications in 2016, Tissuegen also expanded its team by 150 per cent over the last twelve months.

Tissuegen anticipates continued personnel growth in 2016 to further advance, development of Elute fibre applications for pharmaceutical, therapeutic, and medical device customers.

The company also launched its newly redesigned website presenting its roadmap for development of Elute fibre-based pharmaceutical and biologic delivery products.

“Elute fibre enables our pharmaceutical, therapeutic and medical device customers to develop innovative products for FDA submission and clinical application,” said CEO Christopher Knowles.

“We demonstrated our commitment to quality in 2015 with ISO13485:2003 certification, ISO Class 7 clean room installation, and investment in key personnel,” he added.

“With the launch of our redesigned website, continued investment in our talented development team and plans to expand manufacturing capacity for Elute fibre, we are just getting started,” Knowles stated.

Tissuegen won the 2015 R&D 100 Award in the Market Disruptor Service category and the ITMA Future Materials Award for Most Innovative Small Company in 2015.

Tissuegen recently exhibited at MD&M West 2016 and will exhibit Elute fibre at the upcoming MD&M East tradeshow in New York City in June. (AR)

Fibre2Fashion News Desk – India