Associate Director Drug Product Analysis Solvias, Inc Kaiseraugst, Aargau, Switzerland
Live viral nasal vaccines pose significant analytical challenges, particularly for aerosol characterization, as surrogate formulations are not always accepted by regulators. This case study demonstrates how standard nasal spray methodologies can be innovatively adapted to enable safe and efficient testing of a live-attenuated SARS-CoV-2 vaccine under BSL‑2 conditions. Using a structured experimental design, syringes were filled and tested at multiple time points over an 8-hour period to simulate clinical handling scenarios. Key performance attributes—including droplet size distribution, spray pattern, plume geometry, and pump delivery—were assessed using laser diffraction, high-speed imaging, and gravimetric analysis. A layered biosafety workflow was integrated with standard instrumentation, enabling reproducible, scientifically meaningful results without compromising operator safety. This work illustrates how tailored analytical approaches, combining experimental design, instrumentation, and workflow innovation, can overcome complex challenges in pharmaceutical analysis, supporting robust in-use evaluation of high-risk biologics.
Learning Objectives:
Upon completion, participants will be able to design safe analytical workflows for live viral nasal vaccines, evaluating in-use studies under real-world conditions while integrating aerosol testing and BSL‑2 biosafety.
Upon completion, participants will be able to evaluate the performance stability of nasal atomizing devices over clinically relevant timeframes, interpreting droplet size distribution, spray pattern, plume geometry, and pump delivery data to support in-use study protocols.
Upon completion, participants will be able to apply risk assessment principles for airborne droplet contamination using settling velocity calculations and establish appropriate waiting periods and containment procedures when regulatory authorities reject surrogate formulations for device testing.
