Impact of pneumatic tube transportation on the aggregation of monoclonal antibodies in clinical practice.

Postproduction handling and in-hospital transportation of antibody drugs cause mechanical stress, including interfacial and shear stress, that can induce antibody unfolding and aggregation. The handling practices differ significantly between hospitals and the impact on protein stability is unknown. For example, the mechanical stress caused by transport via pneumatic tube systems (PTS) on therapeutic antibody aggregation is a potential safety and quality gap.

Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.

Objective: Available guidelines are ambiguous about safe handling monoclonal antibodies (MABs) and whether or not to use a Closed System Drug-Transfer Device (CSTD). In this article we want to describe a standardized working method on handling MABs in a clinical trial setting.

Data Sources: The current workflow at the clinical trial unit of the Ghent University Hospital was critically analyzed, after which an extensive literature review was performed using the National Institute for Occupational Safety and Health Working Group guidelines and the database PubMed (Keywords: monoclonal antibodies, closed system transfer devices, safety guidelines, safe handling, management, administration, (bio)compatibility, volume loss, contamination, clinical trial unit.

Extravasation of monoclonal antibodies commonly used in oncology: Classification, management and the role of the pharmacist.

Introduction: Extravasation by conventional cytotoxics has been well documented. While monoclonal antibodies are not considered to have the necrotic potential of some cytotoxic medicines, they require appropriate management in case of extravasation. However, fewer data are available on their classification and appropriate management when extravasation occurs.

The impact of logarithmic dose banding of anticancer drugs on pharmacy compounding efficiency at Ghent University Hospital.

Background: Dose banding (DB) (dose rounding with predetermined variation with prescription) enables in-advance preparation of high-turnover anticancer drugs with potential benefit for pharmacy compounding work flow.

Objectives: To analyse the impact of potential situations on the efficiency of DB in the pharmacy (safe and maximum storage), calculate preparation lead times and the potential full-time equivalent (FTE) benefit.

Methods: Candidate intravenous anticancer drugs were selected for logarithmic DB according to prescribing frequency, infusion volume and stability (usage data 2015 of the tertiary Ghent University Hospital, Belgium).