Process Analytical Technology in biopharmaceutical manufacturing

Process Analytical Technology (PAT) became a well-defined concept within the pharmaceutical industry as a result of a major initiative by the FDA called "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." The FDA defines PAT as "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality." The biotechnology industry has started incorporating PAT in manufacturing, because of regulatory pressure and because the previous blockbuster-oriented business model is becoming less viable. This thesis proposes a methodology for evaluating PAT systems and delivers guidance on how to develop and implement them to effectively manage risk in biopharmaceutical manufacturing. The methodology includes guidance regarding identifying opportunities, evaluating and implementing novel analytical technology, appropriately applying acquired data, and managing change associated with PAT implementation. Experimental results from a novel PAT system that acquires light scattering and UV absorbance data to control chromatography during large-scale manufacturing are presented as a case study. The case study follows the methodology to show how a system optimized for a laboratory can be scaled for use in biopharmaceutical manufacturing.

Department dc:contributor.department

Leaders for Global Operations Program at MIT

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2013

Author dc:creator

• Cosby, Samuel T. (Samuel Thomas)

Advisor dc:contributor.advisor

• Allan Myerson and Roy Welsch.

• 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/1721.1/80911

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/80911