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
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
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:
Crystallization is a critical process for the purification and isolation of chemical compounds in the manufacture of many fine chemical and pharmaceutical products. The results of the crystallization step have far reaching impacts on overall process efficiency and final product quality. Crystallization is also a very difficult process to effectively optimize and control. Crystallization is inherently complicated simply by being a process involving the creation and formation of solid particles.
Timothy A. Bell, of DuPont Engineering Research and Technology, wrote a review of the challenges of scaling-up particulate processes where he stated: Continue reading
I am excited to be chairing the upcoming In Process Particle Forum focused on Liquid and Solid Dosage Formulations on September 15 in Woodbridge, NJ. This will be the third year in a row that METTLER TOLEDO has brought together expert users of FBRM and PVM to present their cutting edge research to a group of their peers. This year, we have the best agenda yet with four industry papers from:
- Bristol-Myers Squibb
- Johnson and Johnson
One goal of high shear granulation is to yield repeatable endpoint granule size, shape, and density distributions. This is necessary for consistent downstream flow properties, tablet consistency, and content uniformity. Quality by Design (QbD) is a concept applied to gain true process understanding through tools such as Design of Experiment (DoE), risk management, and Process Analytical Technology (PAT).
This extended abstract summarizes collaborative research between GlaxoSmithKline (GSK) and METTLER TOLEDO in the application of process analytical technologies (PAT) to the monitoring, optimization and control of High Shear Wet Granulation.
Zane Arp, GSK
Eric Dycus, Ben Smith, METTLER TOLEDO