After a substantial amount of planning and effort, TissueGen Inc., makers of ELUTE fiber, controlled, sustained drug delivery from bioresorbable fiber, has been awarded ISO13485:2003.
TissueGen Awarded ISO Certification
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As indicated in the March 28, 2016 news release, “To drive continued growth for ELUTE fiber applications in 2016, TissueGen has expanded its team by 150% over the last twelve months, with notable appointments including: Brent Crow, Ph.D., promoted to Head, Special Programs, now leading the company’s development of platform technologies for ELUTE fiber applications; Jennifer Seifert, Ph.D., who joined the company in 2015 to lead application of ELUTE fiber for the treatment of spinal cord injuries and is now serving the company as Director, Research and Development; Michelle Locke joining in January as Manager, Quality and Regulatory Affairs; Principal Scientists Paul Hubbard, Ph.D., Alpesh Patel, Ph.D., and Paul Sood, Ph.D., joining and significantly expanding the company’s expertise in protein, polymer, and pharmaceutical drug delivery technologies; and Andreas Sauerbrey, M.D., and Richard W. Snyder II, M.D., joining the company’s scientific advisory board with industry-leading expertise in the fields of orthopedic and cardiovascular medicine, respectively, to guide the company’s development of ELUTE fiber for clinical application.”
“ELUTE fiber enables our pharmaceutical, therapeutic and medical device customers to develop innovative products for FDA submission and clinical application. We demonstrated our commitment to quality in 2015 with ISO13485:2003 certification, ISO Class 7 clean room installation, and investment in key personnel, ” said TissueGen CEO Christopher Knowles, “With the launch of our redesigned website, continued investment in our talented development team and plans to expand manufacturing capacity for ELUTE fiber—we’re just getting started.”
Knowles told OTW, “TissueGen’s commitment to quality and driving ELUTE fiber-based products to clinical applications for pharmaceutical, therapeutic, and medical device customers was evident this past year. Over the past twelve months, we made significant investments in our infrastructure and team—culminating in the receipt of our ISO13485:2003 certification—to best support customer product applications to the FDA, including the transition of research, development and production activities to an ISO Class 7 facility for the development and manufacture of ELUTE fiber.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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