Predicting Immunogenicity Risk in Biopharmaceuticals

Clinical Aspects of Immunogenicity to Biopharmaceuticals

The range of biopharmaceuticals available is steadily increasing. The first generation of products were copies of naturally occurring growth factors, or hormones or cytokines. With the development of new techniques, such as pegylation and glycosylation, second-generation biopharmaceuticals with increased bioavailability and higher therapeutic index are available. Most biopharmaceuticals induce ...

On risk and plant-based biopharmaceuticals.

Research into plant-based expression of pharmaceutical proteins is proceeding at a blistering pace. Indeed, plants expressing pharmaceutical proteins are currently being grown in field environments throughout the USA. But how are these plants and proteins being assessed for environmental risk and how are they being regulated? Here, we examine the applicability of the risk assessment paradigm fo...

Microbial Quality Concerns for Biopharmaceuticals

Plant-based production of biopharmaceuticals.

Plants are now gaining widespread acceptance as a general platform for the large-scale production of recombinant proteins. The first plant-derived recombinant pharmaceutical proteins are reaching the final stages of clinical evaluation, and many more are in the development pipeline. Over the past two years, there have been some notable technological advances in this flourishing area of applied ...

Biopharmaceuticals: an overview

Biopharmaceuticals drugs structurally mimics compounds found within the body and are produced using biotechnologies. These have the potential to cure diseases rather than merely treat symptoms, and have fewer side effects because of their specificity, for example, cytokines, enzymes, hormones, clotting factors, vaccines, monoclonal antibodies, cell therapies, antisense drugs, and peptide therap...