BioACCESS Projects

Economic evaluation of manufacturing options for the global supply of biologic therapies: location-dependent costs and risks.

Within biomanufacturing networks, various design options are emerging for drug substance, drug product and fill-finish operations: facility type (e.g. stainless steel vs. single use disposable systems), process (e.g. fed batch vs. continuous), capacity utilization (e.g. single vs. multi-product), business model (e.g. in-house vs. CMO), formulation (e.g. single vs. multi-dose syringe), location of facilities relative to each other and disease burden, allocation of capacity across sites, and more. The relative impact of various design options and process changes on manufacturing cost has been elaborated in a number of papers, but there continues to be uncertainty as to the best use of resources, design of policies, and development of technologies that will have the most cost-effective impact on maximizing the supply of and access to biologics. Analytical and decision support tools are needed to help re-orient the biopharmaceutical industry in ways that meet future projected healthcare demand in terms of quantity, quality, and affordability. In this project, quantitative models are being built to allow users to simulate a broad range of design scenarios across geographies, test innovations, and analyze long-term financial and supply risks relative to global therapeutic need.

Output:

  • White Paper – Comparing Centralized vs. Distributed Models of Biologics Manufacturing and Supply for Global Health: A Discussion of Challenges and Opportunities (2017)
  • Masters Thesis – Closing Gaps in Global Access to Biologic Medicines: Building Tools to Evaluate Innovations in Biomanufacturing (2018)

 

Team: Dr. Paul Barone (Center for Biomedical Innovation), Prof. Reuben Domike (Brigham Young University), Dr. John Frenz (Northeastern University), Donovan Guttieres (Center for Biomedical Innovation), Prof. William Hancock (Northeastern University), Dr. James Leung (Center for Biomedical Innovation), Prof. Anthony Sinskey (MIT Biology), Dr. Stacy Springs (Center for Biomedical Innovation)
Support: BioMarin, Brigham Young University, CASSS, Northeastern University

Other Project Areas

  • Manufacturing, supply and logistics modelling for demand-responsive operations
  • Beyond cost-of-goods: total system cost and effectiveness
  • Systems approach to testing innovations and informing decisions for biologics access
  • Case studies of NCDs in specific geographies (e.g. diabetes in India and China)