CFD Supported Investigation of Shear Induced by Bottom-Mounted Magnetic Stirrer in Monoclonal Antibody Formulation.

Purpose: Biological pharmaceutical unit operations like homogenization or pooling of liquids are often performed in stirred vessels. Bottom-mounted magnetic stirrers are usually the system of choice in drug product manufacturing, because bottom-mounted magnetic stirrers are considered to be gentle mixing systems. Nevertheless, magnetic stirrers can cause shear stress and, thus, lead to protein damage.

Factors Governing the Precision of Subvisible Particle Measurement Methods - A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe.

Purpose: The current study was performed to assess the precision of the principal subvisible particle measurement methods available today. Special attention was given to identifying the sources of error and the factors governing analytical performance.

Methods: The performance of individual techniques was evaluated using a commercial biologic drug product in a prefilled syringe container.