Pharmaceutical Technology Europe, Mar 1, 2009 - Pharm Tech Europe

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Pharmaceutical Technology Europe, Mar 1, 2009
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News
News
Pfizer back at the top?; Abating counterfeit medicine fears; Roche sets sight on Genentech; Unfavourable trial results go unpublished
Biopharmaceuticals
PAT: HPLC on the horizon?
By Michael Kraft , George Barringer
PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?
Outsourcing
Evaluating the pieces of the pharma supply chain
By Angie Drakulich , Patricia Van Arnum
After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region?s short? and long?term role?
Validation
Predictive modelling: putting ICH guidelines to work in process validation
By Jason J. Kamm , Philippe Cini
When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
Ask the Expert
Ensuring raw material quality
By Sheelagh Halsey
This month's expert examines the most appropriate technique for checking raw material quality. What technique would you recommend for quality checking of raw materials?
Manufacturing and processing
Quantifying experience in powder processing
By Tim Freeman
Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.
Laboratory Equipment
LC–MS/MS method for the determination of Vitamin D3 in human plasma
By Xuejun Peng , Rong Yi , Amara Pinnawala , Sarah Ostonal , Eliot Chung , Grace van der Gugten , Bernard Nutley , David Gray
An LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
Outsourcing review
Building on the promise of biotech
By Faiz Kermani
The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?
Inside Out
Facilitating technology transfer to your CMO
Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.
Editor's Comment
Goodbye and hello
By Fedra Pavlou , Bibiana Campos-Seijo
This month's editor's comment.
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