Commitment and investment to develop the use of Process Analytical Technology (PAT) is a primary reason why the pharmaceutical industry is able to find ways to streamline and improve manufacturing processes. However, there are significant challenges when implementing Process Analytical Technology (PAT) into larger-scale manufacturing, such as compatibility of measurement instrumentation with classified hazardous areas and the existing processing infrastructure. Even more important is how to sample the chemistry in situ. The majority of reactor vessels in commission today lack suitable entry points for the measurement technology that requires there modification or replacement, which can significantly increase project costs or prohibit implementation entirely. Continue reading →
Three speakers from the 2010 In-Process Particle Forum will present at IFPAC [International Forum Process Analytical Technology] on January 21, 2011 in Baltimore, MD. Steve Mehrman of Johnson & Johnson and James Butz of Merck & Co. are scheduled to present during the Particle Characterization/Analysis-Ultrasound Spectroscopy Friday AM V session at IFPAC. Kevin Macias of Bristol-Myers Squibb will present during the Control Strategies for Drug Product Development and Manufacturing Friday AM VII session. Continue reading →
As I look ahead to 2011, an event of interest is EuroPACT 2011: the second European Conference on Process Analytics and Control Technology. The EuroPACT 2011 event will be held April 26 to 29 in Glasgow. Founded in 2006, the EuroPACT conference covers new technologies in process analytics and process performance monitoring, and the implementation of these technologies in various technological fields, including the transformation of data into knowledge, and industrial sectors.
One poster presentation that I wanted to highlight is – Faster Optimization and Troubleshooting with Process Analytical Technology: Real-time Measurement of the Crystal Population. Continue reading →
At the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting in Salt Lake City, there were a number of well-attended sessions dealing with the related topics of Quality by Design (QbD) and Process Analytical Technologies (PAT). Continue reading →
This week, I was in New Orleans attending the 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The AAPS Meeting combines a large trade show with technical presentation and poster sessions running in parallel.
At the 2010 AAPS meeting, hot topics included Quality by Design (QbD), Process Analytical Technology (PAT) and the drive towards real-time release for pharmaceutical products. FBRM and PVM technologies were well represented with numerous posters and presentations focusing on their use to understand, optimize and control particle size distribution during drug product formulation. Continue reading →
In Situ Monitoring of Biomass, Cell Growth and Cell Agglomeration
Real-time monitoring of the cell population within a bioreactor provides invaluable information regarding biomass concentration and growth kinetics that can be essential for detailed characterization and control of the fermentation process. Additionally, real-time information related to cell morphology, aggregation, and floc size have also been documented and shown to aid in the understanding and optimization of bioprocesses. Continue reading →
The 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting will be held November 14 to 18 in New Orleans. As thousands of pharmaceutical scientists from around the world prepare to gather for the AAPS conference that is being held in conjunction with the International Pharmaceutical Federation’s (FIP) Pharmaceutical Sciences World Congress (PSWC), I wanted to highlight some papers that will discuss how to track particle distribution in real-time: