Spray drying as part of the continuous manufacturing value proposition at Novartis

Novartis Technical Operations is considering a complete overhaul of their manufacturing processes. To date, all drugs have been made by using a batch process. In an attempt to lower costs, Novartis is evaluating moving some drug production to a continuous process. Novartis has instituted lean in their production plants and it has been very successful, but what is on the table now is a way to bring lean to the highest level, and a chance to make a seismic shift in manufacturing performance. The continuous manufacturing initiative between Novartis and MIT exists to pursue that idea. My task was to evaluate the economic impact and feasibility of spray drying on drug manufacturing. Spray drying is an advanced manufacturing technique that could allow Novartis to skip multiple steps in chemical & pharmaceutical operations. It is also a process that can be used continuously. I investigated the use of spray drying with X, one of the drugs in Novartis' product pipeline. The major results of this investigation are that drug solubility in the solvent is a critical variable and that X is stable after spray drying. All experiments in the scientific section were performed with the drug dissolved in Ethanol, and all experiments resulted in stable versions of X combined with various additives. The drug solubility directly affects the number of spray dryers necessary for production within an allocated time span. Using economic assumptions that are detailed later in this work, there is a breakeven point for most drug volumes at around 3% drug solubility, assuming additives poses no problems for dissolution.

Department dc:contributor.department

Leaders for Manufacturing Program at MIT

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2009

Author dc:creator

• Youngman, Adam (Adam Joshua)

Advisor dc:contributor.advisor

• Roy E. Welsch and Bernhardt Trout.

• Sloan School of Management.
• Materials Science and Engineering.
• Leaders for Manufacturing 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/1721.1/50101

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/50101