Navigation Links
Organogenesis Shares Successes and Best Practices for Cell-Based Product Manufacturing at the 6th Stem Cell Product Development and Commercialization Conference
Date:4/6/2017

CANTON, Mass., April 6, 2017 /PRNewswire/ -- 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.

CONTACT:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/organogenesis-shares-successes-and-best-practices-for-cell-based-product-manufacturing-at-the-6th-stem-cell-product-development-and-commercialization-conference-300436140.html


'/>"/>
SOURCE Organogenesis Inc.
Copyright©2017 PR Newswire.
All rights reserved


Related biology technology :

1. Congressman Joe Kennedy III Tours Massachusetts-Based Biotech Firm Organogenesis Inc.
2. Organogenesis Awarded a 5-Year Federal Supply Schedule Agreement with the Department of Veteran Affairs
3. Organogenesis Presents Findings from Groundbreaking Research Highlighting the Healthcare Resource and Economic Burden of Venous Leg Ulcers and Diabetic Foot Ulcers
4. PerkinElmer Shares Future Trends to Improve Testing Systems
5. Marken Shares Recent Client Survey Results
6. Bayer Shares the Risk with Cotton Growers
7. Intrexon Announces a Special Stock Dividend of Shares of AquaBounty Technologies
8. Asymmetrex Director Shares Vision for Company and Private Stem Cell Treatment Clinics in Two Arena International Event Group Forums
9. AltaVoice Shares Data on Diseases from its Patient Insights Network
10. Imprimis Pharmaceuticals Announces Completion of Public Offering of Common Stock and Exercise in Full of Underwriters Option to Purchase Additional Shares
11. Ambry Genetics Shares New Data on Genetic Causes for Neurodevelopmental Conditions, Further Adding to Growing Body of Evidence in Neurology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... DuPont Pioneer and recently formed ... entered into a multiyear collaboration to identify and characterize novel CRISPR-Cas nucleases. The ... gene editing across all applications. , Under the terms of the agreement, Pioneer ...
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, a ... biotechnology industries to improve patient outcomes and quality of life, will now be ... are being attributed to new regulatory requirements for all new drug products, including ...
(Date:10/11/2017)... ... October 11, 2017 , ... The CRISPR-Cas9 ... overexpression experiments and avoiding the use of exogenous expression plasmids. The simplicity of ... performing systematic gain-of-function studies. , This complement to loss-of-function studies, such as ...
(Date:10/11/2017)... , ... October 11, 2017 , ... ... announced today it will be hosting a Webinar titled, “Pathology is going digital. ... Associates , on digital pathology adoption best practices and how Proscia improves lab ...
Breaking Biology Technology:
(Date:4/11/2017)... 11, 2017 Crossmatch®, a globally-recognized leader ... today announced that it has been awarded a ... Activity (IARPA) to develop next-generation Presentation Attack Detection ... "Innovation has been a driving force within Crossmatch ... allow us to innovate and develop new technologies ...
(Date:4/11/2017)... 11, 2017 No two people are ... the New York University Tandon School of Engineering ... found that partial similarities between prints are common ... mobile phones and other electronic devices can be ... vulnerability lies in the fact that fingerprint-based authentication ...
(Date:4/6/2017)... Forecasts by Product Type (EAC), ... End-Use (Transportation & Logistics, Government & Public Sector, Utilities ... Generation Facility, Nuclear Power), Industrial, Retail, Business Organisation (BFSI), ... you looking for a definitive report on the $27.9bn ... ...
Breaking Biology News(10 mins):