Evaluation of post-production handling practices of monoclonal antibodies throughout the world

Abstract Introduction: This survey aimed to create a snapshot of the post-production handling of monoclonal antibodies in daily practice in health-care facilities in several parts of the world. Methods: A worldwide web-based survey was distributed among pharmacists between November and December 2020. The questions were categorized in sections related to storage conditions, reconstitution practices including the use of medical devices, administration practices, transportation, visual examination and shelf-life of mAbs, education of health-care professionals, and patient's home-administration. Results: A total of 247 responders from 37 countries around the world participated in the survey. Hospital pharmacists were the largest group of respondents (92%). Most of the respondents (92%) reported that they store the mAbs at 2 to 8°C and 71% protect the prepared ready-to-administer mAbs from light by secondary packaging. The participants used spikes (38%), closed system transfer devices (CSTDs) (12%), and needles (22%) or a combination of these (28%) as a medical device, and 89% perform the reconstitution practices manually, versus 4% by semi-automatic pump system, 1% by robot, and 5% by a combination of these reconstitution methods. The respondents reported that in their institution, after compounding mAbs are transported via a logistic employee on foot at ambient temperature (59%) or in a cool-box (20%), or via the tube system (7%). More than half (64%) do not have written guidelines for transportation, but 86% perform a visual examination for particles of prepared mAbs before administration. Furthermore, 52% of the responders answered that nurses as well as pharmacists and pharmacy assistants receive staff training on the potential risks of mAb handling. Conclusion: There is a high level of variability in daily practices of mAb handling in pharmacies worldwide.