Formulation and Quality – Biomolecular
2019 PharmSci 360
Closed System Transfer Devices (CSTDs), when appropriately designed and used, are meant to offer enhanced protection to healthcare personnel against occupational exposure of harmful drugs during clinical preparation and administration. Although there has been much focus on CSTDs in the context of drug containment and safety, there has not been much discussion on the compatibility of these devices with biological drug products. This talk will address the complex challenges associated with using CSTDs from a drug product perspective including biologic compatibility and hold-up volume concerns. These aspects are especially crucial given the impending USP General Chapter, which will mandate healthcare personnel to use CSTDs for the preparation and administration of all biologics that are included in the NIOSH list of antineoplastic and other hazardous drugs.