Chapter 35 - Manufacturing challenges and solutions for regenerative medicine technologies

Abstract

Manufacturing is the critical challenge that limits the translation of a regenerative medicine technology into a commercial product. This chapter will start by surveying the current regenerative medicine manufacturing landscape by taking a look at the major manufacturing challenges that regenerative medicine technologies face and what manufacturing solutions can overcome these challenges and greatly accelerate process development. We will then cover some of the top manufacturing challenges for tissue engineering and regenerative medicine such as cost of goods, automation, cell expansion, quality control, shipping and logistics, and standards. We will then cover some of the current solutions that have been developed to address each of these manufacturing challenges. Finally, we will consider business development considerations for tissue engineering and regenerative medicine.