Biological drug products—including monoclonal antibodies and protein-based therapeutics—must be administered parenterally and are highly sensitive to environmental stressors such as mechanical agitation, light exposure, and freezing. In addition to these external factors, the materials and devices used during preparation and infusion can also introduce degradation risks due to shear stress or incompatibility.  This session explores how formulation scientists anticipate and mitigate such risks during product development and manufacturing scale-up. Drawing from both research and industry experience, the presentation highlights strategies designed to ensure biologics remain stable and effective after leaving the manufacturing site. Insights from a recent nurse-focused survey on biologic handling will also be shared, along with discussion of their potential implications for future product design. The session concludes by identifying nurse-informed opportunities to make biologics more resilient and user-centric.  

Learning Objectives: By the end of this session, participants will be able to: 

• Discuss the sensitivity of biological drug products related to improper handling  and administration. 
• Recall the proper product handling required to reduce the risk of degradation. 
• Describe common nursing practices in the handling and administration of biologics. 

Contact Hours: 1

CRNI^® RUs: 2