Biopharmaceuticals are drugs which are based on naturally occurring proteins (antibodies, receptors, cytokines, enzymes, toxins), nucleic acids (DNA, RNA) or attenuated microorganisms. Immunogenicity of these agents has been commonly described and refers to a specific antidrug antibody response. Such immunogenicity represents a major factor impairing the efficacy of biopharmaceuticals due to bi...

Many therapeutically effective animal-derived biopharmaceuticals and biomaterials, e.g., bovine thrombin, heparin and collagen, have been used successfully for decades during surgery, despite the potential formation of antibodies. Whether biological products are derived from human or animal sources or are recombinant proteins, an antigenic response can be provoked by many different factors inhe...

(14)C has long been used as a tracer for quantifying the in vivo human metabolism of food components, biopharmaceuticals, and nutrients. Minute amounts (< or =1 x 10 (-18) mol) of (14)C can be measured with high-throughput (14)C-accelerator mass spectrometry (HT (14)C-AMS) in isolated chemical extracts of biological, biomedical, and environmental samples. Availability of in vivo human data sets...

The progress of genetic engineering has spurred a shift in pharmaceutical development from low-molecular drugs towards biopharmaceuticals. Looking at the top ten drug sales ranking in the world, biotherapeutics, such as Humira (adalimumab), Remicade (infliximab) and Rituxan (rituximab), have progressed substantially, in contrast to lowmolecular blockbusters like Lipitor (atorvastatin calcium) o...

A T THE beginning of the 20th century the medicines market was dominated by preparations derived from natural sources of plant, animal or mineral origin. Later these were replaced by synthetic molecules discovered in the laboratory and produced in large scale chemical plants. These drugs had an advantage over the natural products because they were consistent in their molecular structure and cou...