Process Development

Oct 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
Aug 01, 2012
Pharmaceutical Technology
The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.
Jul 02, 2012
Pharmaceutical Technology
Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.
May 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.
Nov 01, 2011
Pharmaceutical Technology Europe
June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.
Sep 02, 2011
Pharmaceutical Technology
Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
Aug 02, 2011
Pharmaceutical Technology
Quality management requires more effort in a complex supply chain.
Aug 01, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.
Aug 01, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.
Apr 02, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The need for greater process understanding raises the bar for suppliers.
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