Subvisible particles are a critical quality attribute (CQA) for protein therapeutics that can limit a product’s shelf-life and induce immunogenicity. In this Halo University lecture, we present Side-Illumination Membrane Imaging (SIMI) and Fluorescence Membrane Microscopy (FMM) as two high-throughput techniques built into the Aura platform for subvisible particle identification. SIMI identifies external contaminants such as plastics, glass, and metals, while FMM rapidly identifies biological aggregates. Together, this multi-modal approach provides a sensitive method for monitoring the quality and stability of protein formulations. Here, we focus these techniques on rapidly identifying subvisible protein aggregates, degraded polysorbate aggregates, and non-biologic particle contaminants.
Key Learning Objectives:
- Readily identify unexpected external contaminants using Side-Illumination Membrane Imaging.
- Rapidly identify protein aggregates using Fluorescence Membrane Microscopy
- Accurately distinguish protein aggregates from polysorbate degradants using Fluorescence Membrane Microscopy
About the speaker:
Dr. Ari Hernandez is a Field Application Scientist at Halo Labs. He earned his MD and PhD through the Medical Scientist Training Program at the University of Colorado. His PhD is in molecular biology with a focus on targeted therapeutic approaches against head and neck cancer. He joined Halo Labs as he believes he can help more patients by supporting pharmaceutical companies to develop safer formulations through the Aura platforms.
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