Scale Up

Feb 01, 2011
Pharmaceutical Technology
The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.
Jan 27, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.
Nov 01, 2010
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.
Sep 02, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.
Sep 01, 2010
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.
Apr 19, 2010
Equipment and Processing Report
By Pharmaceutical Technology Editors
If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.
Mar 17, 2010
Equipment and Processing Report
By Pharmaceutical Technology Editors
Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?
Jan 20, 2010
Equipment and Processing Report
By Pharmaceutical Technology Editors
Could flexible manufacturing change the standards for biopharmaceutical production? To find out, Equipment and Processing Report talked to James Robinson, vice-president of technical and quality operations at biotechnology company Novavax (Rockville, MD).
Jan 14, 2010
Equipment and Processing Report
By Pharmaceutical Technology Editors
The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.
Nov 18, 2009
Equipment and Processing Report
By Pharmaceutical Technology Editors
Recent advances in microreactor technology are improving the application and scale at which the technology can be applied.
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