Modeling and economic evaluation of early stage clinical monoclonal antibody manufacturing using single use technology

A critical cost driver in the product development process is the manufacturing of clinical trial material supplies. The clinical manufacturing process operates under similar regulatory burdens as commercial biopharmaceutical manufacturing, but must operate with a high degree of flexibility to respond to emerging data from ongoing clinical programs and competitive intelligence. This project investigates the current state of clinical monoclonal antibody (mAb) manufacturing and generates possible future states for low-cost, flexible manufacturing. Pfizer currently has a world-class clinical manufacturing facility in St. Louis, MO, and forecasts have not predicted sufficient growth in the market to justify additional facilities under the current strategy. However, with many other companies turning to single-use technology, Pfizer would like to consider the benefits of a new low-cost, flexible facility for the benefits of flexibility and faster speed to market. A high-level facility model includes capital costs, technical specifications, and a dynamic view of the operational costs based on product attributes. This model shows that a campaign cost of less than $2.6M can be achieved with only 3 projects per year, which represents a facility utilization of less than 40%. At a loading of 4 campaigns per year, this facility would have a payback period of less than 3 years. The conservative facility design shows how capacity can be added with a low operational cost and less than $5M of overhead per year. Business factors such as pipeline prospects and availability of capital may prevent execution of the project in the near term, but investment in single-use equipment is advisable to gain experience in technologies that are likely to play a large part in biopharmaceutical manufacturing in the future.

Department dc:contributor.department

Leaders for Global Operations Program at MIT

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2015

Author dc:creator

• Kress, Daniel Evan

Advisor dc:contributor.advisor

• J. Christopher Love and Retsef Levi.

• Sloan School of Management.
• Chemical Engineering.
• Leaders for Global Operations Program.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/99031

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/99031