Application of Portable Spectrometers in Pharmaceutical Forensics

Pharmaceutical forensics is a unique industry field, where samples of unknown identity, composition, quality, or origin are analysed. Every case differs in nature, ranging from detection of counterfeit drug products, evaluation of patient complaints, and analysis of foreign/extraneous matter from manufacturing investigations. Portable spectrometers have many applications in this industry due to the compact, fast, and in-field capabilities of the instrumentation. The objective of this presentation is to highlight real-world applications of portable technologies in the pharmaceutical forensics field such as screening/testing of counterfeit drug products, moisture analysis of disintegrated tablets, and more.

Presented by Brittany Handzo, Scientist, Forensics and Innovative Technologies at Bristol-Myers Squibb

Brittany Handzo is a Scientist at Bristol-Myers Squibb (NJ) working within the Forensics and Innovative Technologies (FIT) team for the past five years. Her roles include performing analytical testing support for various investigation types such as product quality complaints, suspect product/counterfeit cases, particulate/foreign matter manufacturing complaints, and cell therapy requests. A variety of analytical techniques are used for these investigations, including microscopy, spectroscopy, elemental, chromatography, and portable technologies. Brittany holds a BS Chemistry from Fairleigh Dickinson University and a MS Chemistry from Seton Hall University.

Ravi Kalyanaraman, PhD, Director of the Forensics and Innovative Technologies at Bristol-Myers Squibb

Ravi Kalyanaraman, PhD is the Director of the Forensics and Innovative Technologies (FIT) group within Global Quality Control Analytical Science and Technology at Bristol‑Myers Squibb (BMS) Company. He received his PhD from the University of Idaho in 1995 and did his post-doctoral work at the University of Puerto Rico. He has been with BMS since 2002 and his work has focused on leading and developing new and novel analytical techniques to detect pharmaceutical counterfeits, and to support particulate and foreign matter characterisation in the manufacturing process (bio, pharma, and cell therapy). His interests are mainly in using vibrational spectroscopic techniques, such as Raman, mid- and near-infrared (NIR) and hyperspectral imaging for pharmaceutical counterfeit detection. His group extensively uses microscopy (IR, Raman and SEM) and energy dispersive spectroscopy (EDS) for elemental analysis for particulate and foreign matter investigations. He leads a team in global quality organisation that is involved in the analysis of products received from patient complaints and from corporate security groups. His group also support Process Analytical Technology (PAT) methods for pharma products in commercial operation.