Protein monoclonal

Lutgens E, Faber B, Schapira K, et al. Gene profiling in atherosclerosis reveals a key role for small inducible cytokines validation using a novel monocyte chemoattractant protein monoclonal antibody. Circulation 2005 111(25) 3443-3452. 

Rabies virus protein Monoclonal antibody (mAb S057) Rabies virus neutralization N. tabacum cv Xanthi 35 S MSP +KDEL + 3 pg/g FLW (0.07% TSP) 33... 

The application of the SMB-technique to the downstream processing of biotechnological products requires some specific changes to meet the special demands of bioproduct isolation. Some exemplary applications are given including separations of sugars, proteins, monoclonal antibodies, ionic molecules and optical isomers and for desalting. 

Mammalian cells are commonly employed for the production of therapeutic and diagnostic proteins, since they are able to correctly synthetize the large and complex structures that the human body requires as medicine [1]. Nowadays, they are employed for the large-scale production of recombinant therapeutic proteins, monoclonal antibodies (MAbs) and viruses used in the preparation of vaccines (e.g. against rabies, hepathytis B, polio, etc) [2]. An overview of some licensed/approved products derived from mammalian cell culture is given in Table 1. 

Foreign Proteins monoclonal antibody, interleukins, GM-CSF, various enzymes... 

Foulkes J, Traynor G (1999), Regulation of antibodies and recombinant proteins, In Rehm HJ, Reed G, Ptthler A, Stadler P (Eds), Biotechnology, 2nd Ed., vol. 5a, Recombinant Proteins, Monoclonal Antibodies and Therapeutic Genes, Wiley-VCH, Weinheim, pp. 495-516. 

The biological activities of the product are influencing the immune response. An immune stimulating therapeutic protein is more likely to induce antibodies than an immune suppressive protein. Monoclonal antibodies targeted to cell bound epitopes are more likely to induce an immune response than monoclonal antibodies with a target in solution [20], Also the Fc bound activities of monoclonal antibodies have an influence. A monoclonal antibody with a modified Fc part has been reported to be less immunogenic than the unmodified monoclonal antibody [21],... 

The biopharmaceuticals sales are about 45 billion and represent 10 percent of the total pharma market. Today, 25 percent of new drugs are biopharmaceuticals. Since the introduction of insulin over 25 years ago, 160 biopharma products, ranging from proteins, monoclonal antibodies, and nucleic acid-based products, have been approved for use. In 2004 alone, 12 new biopharmaceuticals have been approved, of which only 3 are produced by microbial fermentation, as cell culture is the preferred method for production of biopharma drugs. 

Monoclonal Antibodies and Large Proteins. Monoclonal antibodies (mAb) that target cellular antigens can be labeled... 

Watanabe N, Tanada S, Oriuchi N et al (2000) Tumor uptake of radioiodinated antihuman pulmonary surfactant-associated protein monoclonal antibody PE10 in nude mice bearing hitman pulmonary adenocarcinoma in combination with an unlabeled preload. Nucl Med Biol 27(8) 723-731... 

There has been limited success with monoclonal antibodies, used by themselves, and the antibody product Herceptin is employed in the treatment of certain forms of breast cancer. This antibody targets a protein called ERBB2, which is over-expressed in many breast tumours, and has a normal role as a receptor for endothelial growth factor and thus acts as an upstream activator of Ras-G proteins. Monoclonal antibodies have also been used to eradicate small populations of cancer cells from bone-marrow cells that have been pre-... 

A note on our terminology consistent with our understanding of the industry, we use the term biopharmaceuticals - representing molecules like recombinant proteins, monoclonal antibodies, fusion proteins. 

Dupin, E., Baroffio, A., Dulac, C., Cameron-Curry, P. and Le Douarin, N.M. (1990) Schwann-cell differentiation in clonal cultures of the neural crest as evidenced by the anti-schwann cell myelin protein monoclonal antibody. Proc. Natl. Acad. Sci USA 87 1119-1123. 

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