Biosafety Considerations for Viral Vector Gene Therapy: An Explanation and Guide for the Average Everyday-Hero Pharmacist

Abstract

Purpose: An overview of the multi-faceted biosafety points that must be taken into consideration by pharmacists and pharmacies in order to provide viral vector gene therapy to their practice site. Summary: As science and medicine evolves, pharmacists and other healthcare workers are continually faced with unique challenges in the workplace. They are expected to be informed and proficient on new therapies and standards of practice, and be able to apply this knowledge appropriately for their patients. One such advancement that seems to be picking up speed in recent years is gene therapy, which is often achieved with the assistance of a viral vector. As these viral vector doses move closer to mainstream medicine, a host of issues and concerns for the pharmacists, nurses, and caregivers that are involved in the process begin to rise to the surface, often rooted in the critical concern: “How do we dispense, utilize, and administer these doses safely?” Unfortunately, there is no singular, concise source of information for addressing biosafety with viral vector products, and guidance must be gathered from a variety of resources in order to mesh together a reasonable working process. Conclusion: While this may seem to be a daunting task, facilities that already meet USP 797 and USP 800 guidelines are well on their way to being ready to provide viral vector doses. By incorporating additional steps and reviewing biosafety specific resources, these sites can easily adapt to provide these new and novel therapies for their patient population.