Pharmaceutical Technology Europe
March 01, 2009
Outsourcing
21
3
After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region?s short? and long?term role?
March 01, 2009
Laboratory Equipment
21
3
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.
March 01, 2009
Inside Out
21
3
Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.
March 01, 2009
Outsourcing review
21
3
The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?
March 01, 2009
Validation
21
3
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.
March 01, 2009
Biopharmaceuticals
21
3
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?
March 01, 2009
Biopharmaceuticals
21
3
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.
March 01, 2009
Manufacturing and processing
21
3
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?