C18 - The safe handling of new and emerging therapeutics: from mRNA to cell-based treatments



Dr Laurel Leganza (USA)


The COVID-19 pandemic saw rapid development of vaccines and therapeutics using new technologies including mRNA and targeted monoclonal antibodies. However, this rapid development created questions for practitioners on the appropriate safe handling of these products. Similarly, new and emerging therapies for cancer and other non-communicable diseases are emerging and hold the promise of revolutionising medicine. These therapies often present known and unknown theoretical and real risks to healthcare workers who are working to save the lives of their patients. The increased development and clinical use of bio- and immunotherapies, cell and viral vector therapy treatment modalities often put practitioners and pharmaceutical scientists at odds with each other when deciding the appropriate precautions to take when handling these agents.


16:00 – 16:05      Introduction by the chair
16:05 – 16:30


Comparison of biosafety and hazardous drug safe handling procedures
Dr Michael Ganio, American Society of Health-System Pharmacists, USA
16:30 – 16:55


Implications in pharmaceutical practice of nanomedicines
Dr John Hertig, Butler University, USA
16:55 – 17:20  

Challenges and opportunities for use of closed system drug transfer-devices (CSTDs) with biological agents
Dr Ryan Forrey, Becton Dickinson and Company (BD), USA

17:20 – 17:30



Learning Objectives

  1. To identify the real and potential risks associated with the handling new therapeutics while maintaining efficacy and product integrity of the agents
  2. To describe the approaches to handling new therapeutics to mitigate real and potential risks and maintain product efficacy and quality
  3. To identify the challenges associated with the required handling approaches for new therapeutics
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