Filling of high-concentration/viscosity monoclonal antibody formulations into vials or
syringes by peristaltic pumps is an industrial standard. Control of the peristaltic pump on fill …

Syringe filling, especially the filling of high-concentration/viscosity monoclonal antibody
formulations, is a complex process that has not been widely published in literature. This …

Syringe filling of high-concentration/viscosity monoclonal antibody formulations is a complex
process that is not fully understood. This study, which builds on a previous investigation that …

Syringe filling of high-concentration mAb formulation during manufacturing of large-scale
drug product batches may present challenges such as product deposition onto the area of …

Low volume aseptic filling of parenterals, particularly monoclonal antibodies is becoming
increasingly important with the development of more and more intravitreal drugs and high …

The fill-finish process for vials and syringes, although considered standard in the
biopharmaceutical industry, comes with numerous technical challenges when …

The main goal of this study was to use state-of-the-art instruments for nanoparticle
(nanoparticle tracking analysis and resonant mass measurement) and microparticle …

Filling pump operation is an important cause of particle formation in therapeutic protein
formulations. The goals of the present study were to investigate the impacts of peristaltic …

Challenges to a successful commercialization of a protein drug include maintaining the
safety and efficacy during the drug product manufacturing process and storage until delivery …

Partial and complete clogging of filling needles occurred during syringe filling of a high-
concentration mAb formulation. This caused nonvertical liquid flow, which eventually led to …