Tag Archives: QbD

During the development of proteins for use as biopharmaceuticals, the primary structure (amino acid sequence) is important in defining protein activity. Due to the complex nature of protein drugs, compared to small molecule drugs, biophysical techniques are important tools in…READ MORE >

I recently took part in a question and answer session with BioPharm International about techniques for measuring and characterizing protein aggregates. The full discussion can be viewed here, however I thought I would also use this blog post to summarize…READ MORE >

Quality by Design (QbD) principles are now fast migrating to the analytical laboratory and the generic pharma community offered up some excellent real-life examples last week at the IFPAC annual meeting in Baltimore, MD. The session was chaired by Lawrence…READ MORE >

Despite the fanfare, guidance documents from ICH and the world’s regulatory agencies, a plethora of conferences, much discussion on various social media sites and a good number of examples for QbD implementation, there is little published about where industry really…READ MORE >

I was recently asked to provide my opinion regarding global instrument markets for a round robin piece for the March issue of Drug Development & Delivery. Sometimes you question the merit of these activities; however this one was a subject…READ MORE >