October 23rd 2024
The agreement follows Agilent’s acquisition of Canada-based CDMO BIOVECTRA in July 2024.
Sterile, Automated Sampling Enabling PAT for Biopharmaceutical Manufacturing
October 9th 2013Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.
NMR Reaction-Monitoring as a Process Analytical Technique
November 1st 2011The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.
Researchers Reach Femtogram-Level Chemical Characterization
April 10th 2008Combining atomic force microscopy and infrared spectroscopy, scientists at the University of Illinois have demonstrated a method for simultaneous structural and chemical characterization of samples at the femtogram (10-15g) level.
What's Next In: Analytical Testing
December 2nd 2007Industry and regulatory organizations agree that the current focus on product quality will play a major role in shaping pharmaceutical development in the future. Key to this assessment of quality are the methods and technologies in pharmaceutical analytical testing.
A Raman spectroscopic method to monitor magnesium stearate in blends and tablets
September 1st 2007A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.
Applications of Raman spectroscopy in aqueous environments
February 1st 2007Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.
The role of bracketing and matrixing in efficient design of stability protocols
December 1st 2005This article looks at the use of bracketing and matrixing to lower the number of stability samples required and, consequently, reduce the cost of sample production, testing and management. There is a common misconception that regulatory authorities will not accept such methods, but there is actually an International Conference on Harmonization guideline (ICH Q1D) on the subject. In fact, many of these designs have already been accepted and FDA members were among the first to describe matrixing.