Associate Professor Department of Chemistry, University of Washington
Particles in biopharmaceutical products present significant risks due to their potential to compromise product quality and patient safety. Understanding and controlling particle formation mechanisms is crucial for ensuring product stability during formulation development and manufacturing. However, existing analytical techniques such as microflow imaging and light obscuration lack the sensitivity and resolution to detect particles smaller than 2 μm, and they do not provide chemical information to identify particle composition. In this presentation, we will demonstrate the use of stimulated Raman scattering (SRS) microscopy to monitor the C–H Raman stretching modes of proteinaceous particles and silicone oil droplets formed in prefilled syringe barrels. By comparing the relative signal intensity and spectral features of each component, we show that most particles can be classified as protein–silicone oil aggregates. Additionally, we highlight that morphological features are poor indicators of particle composition. Our SRS method provides a label-free, high-resolution approach to quantify protein aggregation and analyze chemical composition, offering the potential for high-throughput screening and better understanding of aggregation mechanisms in protein therapeutics.
Learning Objectives:
Attendees will gain insights into the technical and regulatory challenges involved in developing combination drug products, particularly for subcutaneous biologics.
Participants will learn how biologic formulations interact with primary packaging and delivery devices, focusing on the factors that influence protein stability and device performance.
The session will present novel strategies and tools to address challenges such as high-viscosity formulations, device-related stress factors, and protein aggregation in biologic-device combination products.
