Proper characterization of subvisible particles is an important part of assessments of critical quality attributes. In addition, protein particles may contribute to the adverse immunogenicity in patients that is observed with many protein products. Thus, product quality and the effectiveness of patient treatments depend on understanding the causes of particle formation and developing effective control strategies. Particle formation can occur at any point in the life history of a product; from initial fermentation to drug product manufacturing to handling by end users to delivery to patients. During the development of manufacturing processes, it is critical to quantify subvisible particles to assure that product quality is not compromised. As an example, the impacts of peristaltic filling pump operation on protein particle formation will be presented.
In this session, we will discuss that the brand of commercially used tubing greatly affected particle formation during the pumping of a model protein and during post-pumping agitation stress. Furthermore, the effects of formulation pH and surfactants will also be a topic. Results indicated that subvisible particle measurements are crucial for understanding fully the impacts of processing and solution conditions on product quality.