The Challenge in Bioprocess Development: From Data to Knowledge - Pharmaceutical Technology

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The Challenge in Bioprocess Development: From Data to Knowledge
The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.

Pharmaceutical Technology

Gary Montague* is professor of bioprocess control in the School of Chemical Engineering and Advanced Materials, Newcastle University, Newcastle upon Tyne, NE1 7RU, United Kingdom, tel. +44 191 2227265, fax +44 191 2225292. Elaine Martin is professor of industrial statistics in the School of Chemical Engineering and Advanced Materials at Newcastle University.

This article was reprinted with permission from Pharmaceutical Technology Europe, 19 (9), 71–75 (2007).

*To whom all correspondence should be addressed.


1. US Food and Drug Administration, Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, (FDA, Rockville, MD, September 2004),

2. A.O. Kirdar et al., "Application of Multivariate Analysis toward Biotech Processes: Case Study of a Cell-Culture Unit Operation," Biotechnol. Prog. 23 (1), 61–67 (2007).

3. A. Inselberg, "Visualization and Data Mining of High-Dimensional Data," Chemomet. Intell. Lab. Syst. 60 (1), 147–159 (2002).


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