| The term 'biopharmaceutical' came into existence in | | | | revealed the existence of many regulatory |
| the 1980s and to describe a class of therapeutic | | | | polypeptides of significant medical potential. The fact |
| protein produced by modern biotechnological | | | | that such polypeptides are produced naturally within |
| techniques, more specifically via genetic engineering or | | | | the body only in minute quantities initially precluded their |
| (in the case of monoclonal antibodies) by hybridoma | | | | large-scale medical application. The development in the |
| technology. This usage equated the term | | | | 1970s of the twin techniques of genetic engineering |
| 'biopharmaceutical' with 'therapeutic protein synthesized | | | | and hybridoma technology marked the birth of the |
| in engineered (nonnaturally occurring) biological | | | | modern biotech era. These techniques facilitate the |
| systems'. | | | | large-scale production of virtually any protein, and |
| Biopharmaceuticals are medical drugs produced using | | | | proteins of medical interest produced by these |
| biotechnology. These are actually proteins (including | | | | methodologies have been coined 'biopharmaceuticals'. |
| antibodies), nucleic acids (DNA, RNA or antisense | | | | More recent developments in biomedical research |
| oligonucleotides) used for therapeutic or in vivo | | | | highlights the clinical potential of nucleic acid-based |
| diagnostic purposes, and are produced by means | | | | therapeutic agents. Gene therapy and anti-sense |
| other than direct extraction from a native | | | | technology are likely to become a medical reality within |
| (non-engineered) biological source. | | | | a decade. The term 'biopharmaceutical' now also |
| The first biopharmaceutical was recombinant human | | | | incorporates the polynucleotide sequences utilized for |
| insulin (rHI, trade name Humulin), which was developed | | | | such purposes. |
| by Genentech and marketed by Eli Lilly and Company | | | | There are lots of potential in this area and |
| in 1982. | | | | pharmaceutical industries are tring to encash the |
| Advances in our understanding of the molecular | | | | intellect and new possibilities using biopharmaceutical in |
| principles underlining both health and disease has | | | | treatment of various diseases. |