New enzyme grade is now available for use in a wide range of applications from initial animal research through clinical trials.
LAKEWOOD, NJ (April 5, 2016) – 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.
About Worthington Biochemical Corporation
Founded in 1947, Worthington Biochemical Corporation is an industry leader in the development and production of high quality purified enzymes, proteins, nucleic acids and cell isolation kits for life science research, diagnostics and biotechnology applications. An ISO9001 Certified, primary manufacturer Worthington meets enzyme requirements from research to scale-up bulk bioprocessing and OEM applications. Worthington Biochemical Corporation is a privately held company, headquartered in Lakewood, NJ and has worldwide distribution through a network of exclusive distributors.
