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Basic Information On Biopharmaceutical

Vinod Singh

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The term ‘biopharmaceutical’ came into existence in the 1980s and to describe a class of therapeutic protein produced by modern biotechnological techniques, more specifically via genetic engineering or (in the case of monoclonal antibodies) by hybridoma technology. This usage equated the term ‘biopharmaceutical’ with ‘therapeutic protein synthesized in engineered (nonnaturally occurring) biological systems’.

Biopharmaceuticals are medical drugs produced using biotechnology. These are actually proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.

The first biopharmaceutical was recombinant human insulin (rHI, trade name Humulin), which was developed by Genentech and marketed by Eli Lilly and Company in 1982.

Advances in our understanding of the molecular principles underlining both health and disease has revealed the existence of many regulatory polypeptides of significant medical potential. The fact that such polypeptides are produced naturally within the body only in minute quantities initially precluded their large-scale medical application. The development in the 1970s of the twin techniques of genetic engineering and hybridoma technology marked the birth of the modern biotech era. These techniques facilitate the large-scale production of virtually any protein, and proteins of medical interest produced by these methodologies have been coined ‘biopharmaceuticals’. More recent developments in biomedical research highlights the clinical potential of nucleic acid-based therapeutic agents. Gene therapy and anti-sense technology are likely to become a medical reality within a decade. The term ‘biopharmaceutical’ now also incorporates the polynucleotide sequences utilized for such purposes.

There are lots of potential in this area and pharmaceutical industries are tring to encash the intellect and new possibilities using biopharmaceutical in treatment of various diseases.

Vinod Kumar Singh
Asst. Manager - IP Informations & Technical Writer - IP/Patent Intelligence
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