Press & Announcements
Organogenesis Shares Best Practices for Rapid Sterility Detection Techniques for Cell-Based Therapies at Future Cell Therapy Commercialization Summit
SVP of Quality Systems Discusses Novel Sterility Test Method When Manufacturing Allogeneic Cell-Based Therapy Products
CANTON, Mass. ‐ June 26, 2017 – Cell therapy scientists, researchers and product developers will learn about advanced rapid sterility detection techniques employed by Organogenesis Inc. at the Future Cell Therapy Commercialization Summit held June 26-28 in Boston, Massachusetts. The summit brings together leading industrial cell therapy experts to discover, debate and discuss how to successfully commercialize personalized cell therapies.
Zorina Pitkin, PhD, Senior Vice President of Quality for Organogenesis, will deliver a presentation titled, "Rapid sterility test method for an allogeneic cell-based therapy product" that will review challenges to ensure microbiological safety for cell-based products, highlight advantages of rapid sterility test methods for cell therapies, and describe an approach to rapid sterility method validation.
The presentation will also focus on best practices and lessons learned through the implementation of a rapid sterility test method for Apligraf®, a cell-based commercial product from Organogenesis. Apligraf is an FDA-approved Class III medical device indicated for the treatment of diabetic foot ulcers and venous leg ulcers.
"Ensuring sterility for a cell-based therapy can be challenging as the time required to perform a conventional sterility test may exceed the product’s shelf life," said Pitkin. "As companies strive to adopt these new technologies, they must ensure through validation that these new rapid detection technologies are appropriate for their intended use and are capable of maintaining a high level of sterility assurance that is at least equivalent to the conventional 14-day USP sterility method."
Pitkin has more than 20 years of experience in the field of biotechnology, including the development of Quality System programs for autologous and allogeneic cellular therapies, biologic/device combination products, and for xenotransplantation. Pitkin holds a Ph.D. in Biological Sciences from the Research Institute of Influenza, Russian Academy of Medical Sciences, and is Regulatory Affairs certified.
About Organogenesis Inc.
Headquartered in Canton, Massachusetts, Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.