The increasing use of multiple immunomodulatory (IMD) agents for cancer therapies (eg
antibodies targeting immune checkpoints, bispecific antibodies, and chimeric antigen …

Objective Here we provide a critical review of the state of the art with respect to non-clinical
assessments of immunogenicity for therapeutic proteins. Key findings The number of studies …

The aim of this tutorial is to introduce the fundamental concepts of physiologically based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …

Abstract SARS-CoV-2, which causes COVID-19, was first identified in humans in late 2019
and is a coronavirus which is zoonotic in origin. As it spread around the world there has …

Quantitative systems pharmacology (QSP) approaches have been increasingly applied in
the pharmaceutical since the landmark white paper published in 2011 by a National …

The promise of viral vector‐based gene therapy (GT) as a transformative paradigm for
treating severely debilitating and life‐threatening diseases is slowly coming to fruition with …

Proteins are an increasingly important class of drugs used as therapeutic as well as
diagnostic agents. A generic physiologically based pharmacokinetic (PBPK) model was …

Immunotherapy and immune checkpoint blocking antibodies such as anti-PD-1 are
approved and significantly improve the survival of advanced non-small cell lung cancer …

Immunotherapy has shown great potential in the treatment of cancer; however, only a
fraction of patients respond to treatment, and many experience autoimmune‐related side …

In silico immunogenicity risk assessment has been an important step in the development
path for many biologic therapeutics, including monoclonal antibodies. Even if the source of a …