When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the fit between a medicinal product and a device? This paper describes the relevant definitions, the existing regulatory framework for combined products (or better the lack thereof), and focuses on stability testing to assess drug or biological-device compatibility.
When Drug Meets Device
October 17, 2019 | By: Lise Vanderkelen and Ruth Verplaetse
Pharmaceuticals and Microbiology Expert
Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...
Ruth Verplaetse, PhD
Ruth Verplaetse received her PhD from the Faculty of Pharmaceutical Sciences at the University of Leuven (Belgium) in 2011. Afterwards, Ruth was active in the field of development and validation of bioanalytical methods with LC-MS/MS. She started at Nelson Labs Europe (formerly Toxikon Europe) in 2016 as study director at the Extractables & Leachables department. In 2017, she became part of the Pharma Services Department where she is involved in identifying organic impurities in drug products, stability testing of drug-device combinations as well as development and validation of analytical methods.