Chapter: Manufacturability of Regenerative Medicine Products for Commercial Scale


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.

 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s