ABSTRACT
In recent years, biotechnologically derived drugs, including proteins, peptides, monoclonal antibodies, and antibody fragments, as well as antisense oligonucleotides and deoxyribonucleic acid (DNA) preparations for gene therapy, have been a major focus of research and development efforts in the pharmaceutical industry. The big pharmaceutical companies and biotechnology companies that have emerged in recent years concentrated on the production of biopharmaceuticals, as well as industry research and development. Biopharmaceuticals are complex drug molecules manufactured by biotechnological means, usually involving live organisms or their active components. Biopharmaceuticals are increasingly used in therapy to treat many metabolic and oncologic diseases, to which the advances in the fi eld of pharmaceutical biotechnology were fundamental for these achievements (Tang et al. 2004). More than 150 biopharmaceuticals have now gained medical approval and several hundred are in the pipeline. Most are protein-based, although two nucleic acid-based products are now on the United States of America/European market. An increasing proportion of approvals are engineered in some way, and advances in alternative production systems and delivery methods will also likely impact upon the approvals profi le over the remainder of this decade (Walsh 2005).
