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 …

Biotherapeutics is a rapidly growing drug class, and over 200 biotherapeutics have already
obtained approval, with about 50 of these being approved in 2015 and 2016 alone. Several …

Therapeutic proteins provide interventions for some of the most complex and intractable
diseases and are an essential part of modern medicine. Immunogenicity is the development …

The pathogenesis of inhibitory antibodies has been the focus of major scientific interest over
the last decades, and several studies on underlying immune mechanisms and risk factors for …

Most native proteins do not make optimal drugs and thus a second-and third-generation of
therapeutic proteins, which have been engineered to improve product attributes or to …

Antigen-specific regulatory T cells (Tregs) suppress pathogenic autoreactivity and are
potential therapeutic candidates for autoimmune diseases such as systemic lupus …

Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases.
Their high specificity to target antigens makes them ideal therapeutic agents for certain …

Immunogenicity is an important consideration in the licensure of a therapeutic protein
because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety …

Background Several studies have suggested Black and Hispanic hemophilia A (HA) patients
in the United States suffer higher incidences of neutralizing anti-FVIII antibodies (inhibitors) …

CRISPR–Cas9 mediated genome editing offers unprecedented opportunities for treating
human diseases. There are several reports that demonstrate pre-existing immune …