An Industry Perspective on the Challenges of Using Closed System Transfer Devices with Biologics and Communication Guidance to Healthcare Professionals.

Abstract Closed system transfer devices (CSTDs) have been used with hazardous drugs for several decades. The goal of this whitepaper is to increase awareness among healthcare professionals, device manufacturers, regulators, and pharmaceutical/biotech companies on the potential issues around the use of CSTDs with biologics drug products to allow their informed use in clinics. Specifically, we discuss the key topics related to the use of CSTDs with biologics products, including components and materials of construction, a breakdown of regulatory, technical, and clinical site-related risks and challenges associated with the use of CSTDs with biological products, gathered from stakeholder discussion at the IQ Working Group conference, and considerations on current testing requirements and communication strategies to drive further dialog on the appropriate use of CSTDs. Given the technical challenges of using CSTDs with biologics, coupled with the current regulations surrounding CSTD approval and proper use, as well as a need for alignment and standardization to enable a consistent strategy for compatibility testing and communication of incompatibilities, it is recommended that global health authorities and other stakeholders seek to understand these issues, in order to alleviate these problems and keep healthcare workers and patients safe from harm.