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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.

References

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), http://www.fda.gov/.

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here