Biologic Drug Product Challenges with Closed System Transfer Devices

Closed System Transfer Devices (CSTDs) are meant to offer protection to healthcare professionals against harmful exposure of hazardous drugs during compounding and administration. Although there has been much focus on CSTDs in the context of drug contamination and safety, there has not been much discussion around the compatibility of CSTDs with biological products and patient safety. This talk will address the major challenges with the use of CSTDs including drug product incompatibility and hold up volume to name a few. These aspects are crucial given the impending USP <800>, which will mandate healthcare professional to use CSTD for compounding and administration of all biologics as per the National Institute of Occupational Safety and Health (NIOSH) list of antineoplastic and hazardous drugs.

Twinkle Christian, Process Development Scientist, Drug Product Technologies Group, Amgen