BioMAN Activities – Research Area 4

Global delivery of biopharmaceuticals

The global nature of biopharmaceutical manufacturing has created significant challenges in terms of assuring supply chain integrity, product quality, regulatory compliance and global delivery of quality therapeutics. Research in this area is focused on examining the effects of globalization on quality, safety, regulation, and risk-based decision making in biomanufacturing as well as the development of novel technologies to enable the low-cost delivery of biopharmaceuticals to resource poor regions. Specific research programs in Theme 4 are focused on:
 

Regulatory Economics of Global Biopharmaceutical Manufacturing

BioMAN research is focused on examining the impact of globalization on quality approaches in biomanufacturing. We aim to identify the managerial, organizational, technical and location specific factors that most impact manufacturing and regulatory performance.

This project has been supported by the Sloan Foundation.

 

Development of Simulation Models for Risk-based Decision-making

BioMAN research is focused on the development of risk-based models to aid in the choosing of global manufacturing locations, capacity utilization for existing networks, and determining value of incorporating Contract Manufacturing Organizations (CMOs).

 

Low-cost Manufacturing

BioMAN research is focused on the development of low-cost manufacturing capabilities that facilitate global delivery (see Flexible Modular Platforms)