Press & Announcements
Organogenesis Shares Successes and Best Practices for Cell-Based Product Manufacturing at the 6th Stem Cell Product Development and Commercialization Conference
Company’s Senior Vice President of Quality Speaks at Expert Panel On Manufacturing and Scalable Processes
CANTON, Mass. ‐ April 6, 2017 – Stem cell scientists, researchers and product developers will learn more about Organogenesis’ state-of-the art manufacturing process and successful commercial-scale production of FDA-approved wound healing therapies at the 6th Stem Cell Product Development and Commercialization Conference held April 6-7 in Boston, Massachusetts. The conference highlights cutting-edge developments in all areas of stem cell research, including the biology, medicine, applications and regulation of stem cells.
Zorina Pitkin, PhD, Senior Vice President of Quality for Organogenesis, will participate in an expert panel to discuss Apligraf® and Dermagraft®, two bioengineered, living cell-based therapies that are produced on a commercial scale by Organogenesis. The presentation will cover the Apligraf manufacturing process and highlight the important role of keratinocyte stem cells in functional Apligraf product.
Apligraf (manufactured near the conference, in Canton, MA), and Dermagraft (manufactured in San Diego, CA), are FDA-approved Class III medical devices indicated for the treatment of diabetic foot ulcers. Apligraf is also indicated for the treatment of venous leg ulcers. More than 1 million units of the products have been shipped to date.
"One of the challenges we see with cell-based manufacturing is the transition from pilot to commercial scale production and the ability to perform large scale manufacturing at a low cost," said Dr. Pitkin. "At Organogenesis, we’ve achieved this successfully through process optimization and product consistency that includes multiple levels of quality control and safety."
In Apligraf, keratinocyte stem cells are required to form the product’s differentiated epidermis and provide increased levels of growth factors and cytokines, so it is vital that these cells are preserved through the manufacturing, shipping and distribution process. Through a scale-up manufacturing process that creates a three-dimensional bi-layered construct, Organogenesis is able to produce a bioengineered product with living cells on a consistent basis that delivers a therapeutic benefit to patients with hard-to-heal wounds.
"With five million Americans affected by diabetic foot ulcers and venous leg ulcers, it’s crucial that we consistently produce and manufacture safe, reliable products that promote healing," added Dr. Pitkin. "Organogenesis is at the forefront of this effort, having developed a successful and reliable manufacturing process."
The 6th Stem Cell Product Development and Commercialization Conference presents information regarding cutting-edge developments in all areas of stem cell research, including the biology, medicine, applications and regulation of stem cells. Topics of discussion include recent developments in pre-clinical and clinical trials of stem cell therapy, regenerative medicine and tissue engineering, cancer stem cells, immunotherapy, stem cell reprogramming, and regulatory policies regarding stem cell research.
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.