Immunogenicity of 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 ...

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 ...

Supramolecular PEGylation of biopharmaceuticals.

The covalent modification of therapeutic biomolecules has been broadly explored, leading to a number of clinically approved modified protein drugs. These modifications are typically intended to address challenges arising in biopharmaceutical practice by promoting improved stability and shelf life of therapeutic proteins in formulation, or modifying pharmacokinetics in the body. Toward these obj...

Microbial Quality Concerns for Biopharmaceuticals

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...