Dealing across the coasts

LAKEWOOD, N.J.—Worthington Biochemical Corp., a leader in the development and production of high-quality purified enzymes, proteins, nucleic acids and cell isolation kits, has announced an expansion of its GMP-compliant enzyme offerings. The company signed a non-exclusive, three-year distribution agreement with San Diego-based Cytori Therapeutics, a late-stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions, for distribution rights to Cytori’s Celase GMP-compliant enzyme. No financial details were disclosed.

“We are very excited and pleased to initiate a partnership for Celase GMP with a respected enzyme manufactured like Worthington, which has decades of experience successfully serving the biomedical research and technology field,” Russ Havranek, director of marketing at Cytori Therapeutics, remarked in a press release.

This deal complements Worthington’s existing catalogue of offerings. James Zacka, vice president at Worthington, says the company produces “several animal/xeno-free (AF) collagenases, nucleases including DNase I, RNase A, T1 and T2 and other proteases for biopharmaceutical, biomedical and bioprocessing application, including the isolation of primary and stem cells for regenerative medicine and artificial organ research, collagen purification and the processing of vaccine components.” For its part, Celase GMP is a proprietary enzyme consisting of a blend of collagenase, neutral protease and buffer sales produced using avian and mammalian tissue-free raw materials, aseptically processed, sterile filtered and highly purified under GMP guidelines. These enzymes are suitable to a wide range of adipose stem cell, biomedical and bioprocessing applications.

“We are excited to offer Cytori’s Celase GMP product to Worthington’s Collagenase and STEMxyme portfolio for biomedical research and related bioprocessing applications,” Von Worthington, president and CEO at Worthington Biochemical, commented in a statement on the deal. “It was very important for us to find an enzyme that meets our stringent requirements for high quality and reproducible performance. This new Celase GMP product offering will be marketed through our catalog, direct sales force, distributor network, e-commerce website and upcoming scientific meetings.”

Zacka forecasts ongoing growth for GMP enzymes, noting that regulatory authorities continue to fine-tune their requirements for “regenerative medicine applications for stem cells, biosimilars protein-based drugs and other biopharmaceuticals,” and that as those regulations take hold, more companies are looking for raw materials that meet the necessary guidelines.

“With growth projections for biologics and biopharmaceuticals estimated over 10 percent per year over the next five to seven years, the demand for animal/xeno-free GMP enzymes and related products is also expected to steadily increase,” he explains. “As a result, many enzyme and media producers have and will continue to increase their AF and GMP quality production capabilities and expand their AF/GMP product offerings. In addition, increased emphasis on minimizing risks from animal-sourced materials by worldwide regulatory authorities will also drive enzyme users and producers toward GMP-grade AF enzymes and other AF raw materials, such as cell culture and fermentation media for production of products for biomedical applications.”

Cytori, Zacka adds, “has invested significant resources to characterize and develop the best-in-class Celase GMP-grade enzyme reagent and related protocols specifically for the isolation of adipose derived stem cells from numerous species and tissue sources. Worthington’s distribution of this product will leverage Cytori’s clinical expertise by providing a GMP clinical-grade enzyme to our worldwide customer base of biomedical researchers investigating a wide range of adipose and other regenerative medicine applications that are quickly evolving from the research stages toward clinical applications. The Cytori Celase GMP-grade product will minimize the regulatory process for these clinical-grade research applications.”