Senior Scientist Pfizer Inc. Andover, Massachusetts
Presentation Description: Silicone-oil is a common lubricant used for various pharmaceutical applications. While it is effective at reducing friction for containers such as pre-filled syringes, it also contributes silicone-oil particles to drug products. With a need to distinguish between inherent and intrinsic particles there has been multiple efforts to evaluate various methods capable of separating silicone oil and protein particulates. Our group has used various methods to distinguish between silicone oil and protein particles in pre-filled syringe drug products. Using MFI we have created an electronic filter using an analysis software, LINK, that uses the various properties of the particle images to classify as either silicone oil or non-silicone oil. Additionally imaging flow cytometry has been explored to fluorescently label silicone oil and protein populations. The collection of results in the work presented here highlights the utility of comparing both methods and treating them as orthogonal approaches for obtaining additional particle information.
list various methods for separating silicone oil from other particle types within a biotherapeutic formulation
understand the contributions silicone oil may play under various scenarios to overall particle load
demonstrate the morphological and optical differences between protein and silicone oil that allow electronic separation of particle types