Increasing attention has been paid to developability assessment with the understanding that
thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid …

One of the key unit operations during the aseptic fill-finish process of parenteral products,
such as biologics, is the filling process of the formulated, sterile filtered drug substance into …

Batch-level inference-based quality control is the standard practice for drug products.
However, rare drug product defects may be missed by batch-level statistical sampling …

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

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 …

This article is presenting completely new observations linked to Polysorbate 80 (PS80)
oxidation in biologics drug product. Indeed, we observed that, in the drug product exposed …

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 …

In this method chapter, we provide a brief overview of the key methods available to measure
self-association of monoclonal antibodies (mAbs) and explain for which experimental …

Genetically modified autologous T cells have become an established immunotherapy in the
fight against cancer. The manufacture of chimeric antigen receptor (CAR) and αβ-T cell …

This article summarizes experimental, theoretical, and computational assessments
performed to understand the effect of filling and suck-back cycle factors on fluid behaviors …