Cumulative updating of approved biopharmaceuticals

Article type: Research Article

Authors: Redwan, EL-Rashdy M.

Affiliations: Antibody Laboratory, Protein Research Department, GEBRI, Mubarak City for Scientific Research and Technology Applications, New Borg EL Arab, 21394, Alexandria, Egypt. Tel.: +20 34593420; Fax: +20 34593423; E-mail: [email protected].

Abstract: By definition, biopharmaceuticals includes the recombinant therapeutics proteins, monoclonal antibody and nucleic acid based-products used for medical purposes, which produce through the biotechnology. It has grown enormously during last 25 years, even that each four pharmaceuticals product contains one biopharmeactical product. This class of therapeutical generates in excess of $50 billion in sales annually. About 150 biopharmaceuticals have now received the medical approval. Actually, this white dimension is supported with strong R&D. The cost-estimated of total R&D per single biopharmaceutical approved molecule will reach $1318 million. The majority of these materials are development and producing in mammalian cell line (70%), prokaryotic systems (15%), and yeast (5%), respectively. Few products are animal-derived, however the rest are completely from human-genes or humanized.

DOI: 10.3233/HAB-2007-163-408

Journal: Human Antibodies, vol. 16, no. 3-4, pp. 137-158, 2007