Process Development

May 02, 2012
Pharmaceutical Technology
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
May 02, 2012
Pharmaceutical Technology
A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.
Nov 10, 2011
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
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.
Sep 01, 2011
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.
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
The need for greater process understanding raises the bar for suppliers.
native1_300x100
lorem ipsum