Analytical technologies for real-time monitoring of biopharmaceutical manufacturing processes

American Laboratory

Volumn 38, Issue 3, 2006, Pages

  Fowler, Elizabeth ^a  

^a Quality and Regulatory Affairs   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MANUFACTURE; OPTIMIZATION; PERFORMANCE; PRODUCT DEVELOPMENT; QUALITY CONTROL; REAL TIME SYSTEMS;

BIOPHARMACEUTICAL MANUFACTURING PROCESSES; PRODUCT SPECIFICATIONS; REAL-TIME MONITORING;

DRUG PRODUCTS PLANTS;

EID: 33646379382     PISSN: 00447749     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (7)

1. Hussein, A.S. Biopharmaceutics and Drug Product Quality: Product Quality: Performance Tests for Drug Products, A Look into the Future. USP Annual Scientific Meeting, Iselin, NJ, Sept 26-30, 2004.
2. FDA Guidance PAT. A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, 2004.
3. International Conference on Harmonization Draft Guidance Q8. Pharmaceutical Development, 2004.
4. Zhang, S.; Adams, C.; Bailey, M.; James, D. A High-Throughput Platform for Purification and Characterization of Monoclonal Antibodies. Pittsburgh Conference, Orlando, FL, Feb 26-Mar 4, 2005.
5. Denkinger, N. In Process Methods for Monitoring Residual Moisture Levels During Freeze Drying Processes. Pittsburgh Conference, Orlando, FL, Feb 26-Mar 4, 2005.
6. Straus, D. The Growth Direct™ System: A Rapid Non-Destructive Method for Microbial Enumeration. Pittsburgh Conference, Orlando, FL, Feb 26-Mar 4, 2005.
7. FDA (2004) Innovation and Continuous Improvement in Pharmaceutical Manufacturing Pharmaceutical CGMPs for the 21st Century, 2004.