Worthington announced today at the Experimental Biology Conference in San Diego, the launch of the new Celase® GMP Enzyme product offering. Manufactured by Cytori Therapeutics, this product line is ideal for cell isolation studies for laboratories looking to facilitate a smooth transition from bench and animal research to downstream clinical applications.
Celase® GMP is a proprietary enzyme containing a unique blend of collagenase, neutral protease and buffer salts that are produced using avian and mammalian tissue-free raw materials, aseptically processed, sterile filtered and highly purified under GMP guidelines. A single, sterile, ready to use enzyme containing both collagenase and a neutral protease is ideal for a wide range of adipose stem cell, biomedical and bioprocessing applications.
“This new Celase® GMP product offering is a cost-effective option for laboratories looking for a high-quality GMP enzyme to support their pre-clinical research,” said James Zacka, vice president at Worthington. “We believe the sooner a researcher recognize a potential for a clinical application it is to their long term regulatory benefit to qualify and use a GMP or equivalent grade of enzyme”
Not all research applications required the use a GMP grade enzyme in early phase studies. However, the recent FDA guidance issued for tissue and cell products specifically cite that GMP grade reagents should be used in drug-type validated processes. Subsequently, both regenerative medicine researchers and clinicians are now looking for GMP quality products with a smoother regulatory approval process as the goal.
“The Cytori Celase® Enzyme is currently used in US FDA approved clinical trials. We are excited to offer a foundational and versatile enzyme for advancing adipose-based research programs from pre-clinical to clinical levels while eliminating the need to perform costly and time consuming bridging studies,” said Jason Streeter, quality engineer at Worthington.