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History
- Published online March 29, 2011.
Copyright & Usage
©PDA, Inc. 2011
Author Information
- Beth Junker*,
- Gargi Maheshwari,
- Todd Ranheim,
- Nedim Altaras,
- Michael Stankevicz,
- Lori Harmon,
- Sandra Rios and
- Marc D'anjou
- Biologics Discovery, Bioprocess Development, Biologics Manufacturing Science & Commercialization, Merck Research Laboratories Information Technology, Merck and Co, Inc.
- *↵ Corresponding author: Beth Junker, RY80Y-130, PO Box 2000, Merck & Co, Rahway NJ, 07065. 1-732-594-7010, beth.junker{at}merck.com
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- Article
- Abstract
- Introduction
- Related Internal Efforts and Recent External Technology Developments
- KM Project Approach
- Concept Phase Project Charter
- Concept Phase Critical-to-Quality (CTQ) Attribute Identification
- Concept Phase Solution Generation
- Design/Optimization Phase Approach
- Current State Quantification Activities To Support Design/Optimization
- Verify Phase Identification of Gaps from the Design/Optimization Phase
- Pilot Principles To Verify Detailed Design
- Implementation Planning
- Continuing Efforts toward KM Success
- Acknowledgments
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
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