CHAPTER: MANUFACTURABILITY OF REGENERATIVE MEDICINE PRODUCTS FOR COMMERCIAL SCALE
Appears in the Encyclopedia of Tissue Engineering and Regenerative Medicine
Available now from Elsevier. Click the link to access the book chapter.
In this article, we focus on the commercial development of regenerative medicine and tissue engineering by discussing some of the major products on the market. Commercialization controlled on all levels (inputs, process steps, analytical methods, outputs, and validation) is the key to successfully develop tissue engineered products with market potential. Implementing actual commercialization of regenerative medicine with efficiency gains and risk reduction through quality by design (QbD), reducing costs in development and production, and ensuring positive process scale up, transfer, and modularization are discussed.