PHARMACEUTICAL FORENSICS FOR SAFE MANUFACTURING AND SUPPLY

Presented by 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.
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.