Published 15 Mar 2016
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 >
Tags: higher order structure, ICH, QbD, Webinars
Published 24 Feb 2015
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 >
Tags: buoyant mass, dynamic light scattering, FDA, morphologi G3-ID, Nanoparticle Tracking Analysis
Published 5 Feb 2013
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 >
Tags: event, FDA, morphologi G3-ID, PAT, pharmaceuticals
Published 13 Dec 2012
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 >
Tags: FDA, PAT, Pharmaceutical Industry, QbD
Published 4 Apr 2012
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 >
Tags: global markets, PAT, pharma, pharmaceuticals, QbD