Pharmaceutical Forensics for Safe Manufacturing and Supply

14th June 2019 | 10.00 am EST | Ravi Kalyanaraman, Director at Bristol-Myers Squibb and Jeremy Peters, Scientist at Bristol-Myers Squibb and Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific |WATCH FOR FREE

Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics. These include Energy Dispersive X-ray spectroscopy (EDS/EDX), Scanning Electron Microscopy (SEM), microscopes, Raman, Infrared (IR) and Near Infrared (NIR) micro-spectroscopy. Energy Dispersive X-Ray spectroscopy (EDS/EDX) is a powerful tool in the evaluation of foreign and particulate matter from a variety of processes and products. Coupled with an SEM, the technique provides a qualitative analysis of the elemental composition of particulate matter on the micron size range. The data from EDS can also be used for semi-quantitative applications when certain analytical criteria are met. Confocal Raman and NIR chemical imaging can successfully determine the chemical composition of the unwanted particulate foreign matter in finished pharmaceutical drug products. A point-by-point mapping technique along with CLS (Classical Least Square) fitting can be used to acquire a Raman chemical map of foreign particle surface and to identify the chemical components. In addition, both Raman and NIR spectroscopy have been widely used to rapidly screen counterfeit drugs. This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.


Presented by Ravi Kalyanaraman, Director at Bristol-Myers Squibb

Ravi Kalyanaraman is a director at Bristol-Myers Squibb Company in Global Quality Analytical Science and Technology group with Global Product Development and Supply. He received his Ph.D. from the University of Idaho in 1995 and did his post-doctoral work at the University of Puerto Rico. He has been with Bristol-Myers Squibb since 2002. His work with Bristol-Myers Squibb has been focused on developing new and novel techniques to detect pharmaceutical counterfeits and to support particulate and foreign matter characterization in the manufacturing process (bio and pharma). His interests are mainly in using vibrational spectroscopic techniques, such as Raman, mid and Near-Infrared (NIR) for pharmaceutical counterfeit detection and for product authentication. His group extensively uses microscopy (IR and SEM) and elemental analysis (EDS) for particulate and foreign matter investigations in pharmaceutical manufacturing process. He leads a team in global quality organization that is involved in the analysis of products received from complaints and from corporate security groups. He also leads a group that supports manufacturing investigations.

Jeremy Peters, Scientist at Bristol-Myers Squibb

Jeremy Peters, is a Scientist at Bristol-Myers Squibb Company in Global Quality Analytical Science and Technology group with Global Product Development and Supply Bristol-Myers Squibb Company. He is currently involved in supporting laboratory testing for particulate and foreign matter investigations using state-of-the-art instrumentations, such as SEM/EDS, microscopy and spectroscopy (mid IR, NIR and Raman). He the past he has worked on developing new and novel techniques for Biological Drug Product Characterization and protein Structure determination. Prior to joining Global Quality Analytical Science and Technology, Jeremy worked at the Syracuse site for BMS where he was responsible for QC testing of Raw Materials used for Drug Substance batches. Jeremy has a Bachelor’s degree in Chemical Engineering from the New Jersey Institute of Technology.

Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific provides reliable extrusion and granulation solutions in pharmaceutical processing. We can help you switch from batch to continuous processing with twin-screw extrusion technology and analytical expertise, and we give scientific support for scale-up of such operations. Our wide range of extruders and granulators, plus our rheometer systems, can help you meet goals faster.

Followed by Why Use Raman Microscopy for Pharmaceutical Forensics?

Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials. All of these aspects of Raman microscopy make it an indispensable tool for pharmaceutical forensics.

Presented by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific

Dr. Robert Heintz is a Product Applications Specialist with the Materials and Structural Analysis Division of Thermo Fisher Scientific. He works in the area of molecular spectroscopy, specifically with the vibrational spectroscopy research products, which include both Raman and FTIR instrumentation. He has a BS in chemistry from the State University of New York at Plattsburgh, and a Ph.D. in inorganic/organometallic chemistry from Cornell University. He did his post-doctoral work with Dr. Kim Dunbar at Michigan State University. Robert joined Thermo Fisher Scientific in 2001 and during his time with the company has worked with all of the vibrational spectroscopy instruments, providing applications support and customer training. Since 2011 his primary focus has been on Raman applications, while still supporting advanced FTIR spectrometers and FTIR microscope applications. Dr. Heintz has numerous published research papers and application notes as well as two book chapters and a patent.

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