Therapeutic proteins have a propensity for aggregation during manufacturing, shipping, and
storage. The presence of aggregates in protein drug products can induce adverse immune …

The subcutaneous route of administration has provided convenient and non-inferior delivery
of therapeutic proteins compared to intravenous infusion, but there is potential for enhanced …

An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool
for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral …

Purpose Protein aggregates have been discussed as a potential risk factor related to
immunogenicity. Here we developed a novel human IgG transgenic (tg) mouse system …

ABSTRACT A major impediment to successful use of therapeutic protein drugs is their ability
to induce anti-drug antibodies (ADA) that can alter treatment efficacy and safety in a …

The success of clinical and commercial therapeutic proteins is rapidly increasing, but their
potential immunogenicity is an ongoing concern. Most of the studies that have been …

The safety of most human recombinant proteins can be evaluated in transgenic mice tolerant
to specific human proteins. However, owing to insufficient genetic diversity and to …

An increasing number of therapeutic proteins are being developed for delivery through the
subcutaneous (SC) route of administration. Relative to intravenous (IV) administration, the …

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 …

Mechanical agitation of monoclonal antibody (mAb) solutions often leads to protein particle
formation. In this study, various formulations of an immunoglobulin G (IgG) 1 mAb were …