A thousand small delays and opportunities for error can snowball over the years of a complex biotherapeutic drug development program. They add up to lost time and increased risk in an endeavor that has little tolerance for either. It doesn’t have to be this way.
To get the most out of recent innovations in biopharma development and QC such as multi-attribute monitoring, it’s time to better connect the systems that manage biopharma data. This series explores the what, the why, and the how of better biopharma data.
If data can throw your biotherapeutic development program into chaos, it can also help move you forward. Let’s see how.
The improvements in LC-MS technology under GxP compliant-ready informatics for biopharmaceutical analysis has prepared the industry to expand the role of MS technologies beyond product characterization toward monitoring product and process quality attributes.
The drug development process requires pharmacokinetic (PK) analysis to be performed as part of safety and efficacy studies in both preclinical species and human subjects. For high-sensitivity bioanalysis, liquid chromatography (LC) coupled to a triple… Read more >
On Wednesday evening after dinner and my usual digestif, I was watching the webcast “Making Ion Mobility Mass Spectrometry Routine” when my son walked by. “Wow dad, that’s kind of cool! What the heck is… Read more >
For many years, the prevailing wisdom has been that in the event of chromatographic coelution, caused by complex samples, what is needed is a high-resolution mass spectrometer that can accurately identify different species contained within… Read more >
Increasing Size, Complexity and Potency: The Bioanalytical Challenge of the Next Decade, was the theme for the 3-day APA India held in Mumbai, India from February 23-25, 2015. Close to 300 attendees gathered to discuss… Read more >