When you think of biological processes, they are complex manufacturing processes with high process variability
Development of robust and reliable bioprocesses can be difficult
Increased risk of contamination due to sampling for offline measurement
Process losses can be high
Process Analytical Technology (PAT) provides a means of improved process understanding, optimization, and control
Return on Investment in Process Analytical Technology (PAT) comes from both R&D and manufacturing. Typically, this is achieved by getting more robust processes to market quicker which ultimately minimizes the process risks from batch to batch and also improves process optimization
Process Analytical Technology (PAT) is critical in the transfer of knowledge from lab to manufacturing
Reduced sampling time and online method minimize contamination risks
Quality by Design (QbD) approach identifies and minimizes manufacturing risk through identification of Critical Quality Attributes (CQAs), what causes variability in CQAs, and control of CQAs
The particle size distribution is a critical parameter in process efficiency and product quality in many pharmaceutical, chemical and industrial processes. The real-time measurement of particle count, dimension and shape of particles as they actually exist in process provides critical process information that speeds up process understanding and enables a better means of real-time measurement and control.
At next week’s World Congress on Particle Technology in Nuremburg, two of my colleagues will be presenting papers covering research and case studies covering a variety of applications of real-time measurement of particle systems using on-line particle characterization tools.
The titles of the four papers that will be presented are listed below :
Specific application examples that Brian will discuss are protein crystallization optimization, scale-up from shaker flasks to pilot scale, cell debris & cell debris flocculation, cell count & cell density monitoring in real time with no need for sampling, and cell culture productivity.