Subvisible particle formation in monoclonal antibody (mAb) drug product resulting from
mixing and filling operations represents a significant processing risk that can lead to filter …

Mixing is an important unit operation in monoclonal antibody manufacturing. The goal is to
achieve homogeneity without compromising product quality. Mixing-induced protein …

Processing equipment involving grinding of two solid surfaces has been demonstrated to
induce subvisible particle formation in monoclonal antibody drug product manufacturing …

Using bottom-mounted mixers, particularly those that are magnetically driven, is becoming
increasingly common during the mixing process in pharmaceutical and biotechnology …

We have observed an interesting phenomenon in which grinding of freeze-dried monoclonal
antibody X (mAb-X) formulation powder resulted to significant protein sub-visible particles …

Abstract Characterization and control of aggregate and subvisible particle formation during
fill–finish process steps are important for biopharmaceutical products. The filling step is of …

Passage of specific protein solutions through certain pumps, tubing, and/or filling nozzles
can result in the production of unwanted subvisible protein particles (SVPs). In this work …

Purposes The primary objectives of this study were to investigate the degradation
mechanisms of freeze-dried monoclonal antibody (mAb) formulations under mechanical …

Monoclonal antibodies have proved to be a highly successful class of therapeutic products.
Large‐scale manufacturing of pharmaceutical antibodies is a complex activity that requires …

Proteins are susceptible to degradation upon exposure to a variety of stresses during
product manufacturing, transportation and storage. In this study, we investigated the …