Pharmaceutical Technology Europe-03-01-2009

Pharmaceutical Technology Europe

PAT: HPLC on the horizon?

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?

Quantifying experience in powder processing

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.