Analytical techniques are improving every day, but there still aren't methods sensitive enough to analyze the media used for cell culture, or to monitor the biopharma product (to optimize structure) during cell culture. A year-old research project sponsored by Bristol-Myers Squibb may change that picture within the next few years, and has great implications for Process Analytical Technologies (PAT) and bioanalytics.
It also has huge potential implications for biosimilars and biogenerics, since regulators require extensive proof of comparability. Could more sensitive analytical methods reduce, or even eliminate the need for clinical trials for these drugs? Click here for more on this research in an article written by BMS senior scientist Declan Moran and his colleagues professors Dermot Diamond of Dublin City University and Terry Smith of National University Galway. Lab-on-a-chip, Time-of-Flight spectoscopy, microfluidics and chromatography are just parts of a much bigger picture.
-AMS
