Process Development

Sep 01, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
Aug 20, 2013
By Pharmaceutical Technology Editors
Agencies collaborate to ensure consistent product quality.
Jun 26, 2013
Pharmaceutical Technology
Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.
Apr 15, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
An introduction to the upcoming Interphex panel--Lessons Leaned: Successes and Challenges in Implementing Quality by Design.? Moderator: Jennifer Markarian, manufacturing editor, Pharmaceutical Technology. Panelists: John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co. Chris Moreton, FinnBrit Consulting Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management
Apr 02, 2013
Pharmaceutical Technology
The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
Mar 29, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation, which will be presented at Interphex 2013
Mar 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.
Mar 01, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.
Nov 01, 2012
Pharmaceutical Technology
The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.
Oct 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
This study examines the effect and interaction of variations in hypromellose physicochemical properties.
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