Biotechnology has contributed to the discovery and manufacturing of traditional small molecule pharmaceutical drugs as well as drugs that are the product of biotechnology – biopharmaceutics. Modern biotechnology can be used to manufacture existing medicines relatively easily and cheaply. The first genetically engineered products were medicines designed to treat human diseases. To cite one example, in 1978 development of synthetic humanized insulin by joining its gene with a plasmid vector inserted into the bacterium Escherichia coli. Insulin, widely used for the treatment of diabetes, was previously extracted from the pancreas of abattoir animals (cattle and/or pigs). The resulting genetically engineered bacterium enabled the production of vast quantities of synthetic human insulin at relatively low cost. The application of biotechnology to basic science (for example through the Human Genome Project) has also dramatically improved our understanding of biology and as our scientific knowledge of normal and disease biology has increased, our ability to develop new medicines to treat previously untreatable diseases has increased as well.
Monoclonal antibodies (mAb or moAb) are antibodies that are made by identical immune cells that are all clones of a unique parent cell. Monoclonal antibodies can have monovalent affinity, in that they bind to the same epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different plasma cell (antibody secreting immune cell) lineages. Bispecific monoclonal antibodies can also be engineered, by increasing the therapeutic targets of one single monoclonal antibody to two epitopes.
Given almost any substance, it is possible to produce monoclonal antibodies that specifically bind to that substance; they can then serve to detect or purify that substance. This has become an important tool in biochemistry, molecular biology, and medicine. When used as medications, non-proprietary drug names end in -mab and many immunotherapy specialists use the word mab acronymically.
The idea of a "magic bullet" was first proposed by Paul Ehrlich, who, at the beginning of the 20th century, postulated that, if a compound could be made that selectively targeted a disease-causing organism, then a toxin for that organism could be delivered along with the agent of selectivity. He and Élie Metchnikoff received the 1908 Nobel Prize for Physiology or Medicine for this work, which led to an effective syphilis treatment by 1910.
In the 1970s, the β-cell cancer multiple myeloma was known. It was understood that these cancerous β-cells all produce a single type of antibody (a paraprotein). This was used to study the structure of antibodies, but it was not yet possible to produce identical antibodies specific to a given antigen.
In 1975, Georges Köhler and César Milstein succeeded in making fusions of myeloma cell lines with β-cells to create hybridomas that could produce antibodies, specific to known antigens and that were immortalized. They shared the Nobel Prize in Physiology or Medicine in 1984 for the discovery.
In 1988, Greg Winter and his team pioneered the techniques to humanize monoclonal antibodies, eliminating the reactions that many monoclonal antibodies caused in some patients.
Previously the outcome of some disease like Rheumatoid Arthritis, Ankylosing Spondylitis, Vasculitis, SLE and many types of cancer were very much frustrating and therapeutic options were very limited but after the introduction of biotech products like mAbs a revolutionary change has occurred in these arena.
Ziska proudly announces its biotech project in Bangladesh in 2017 and we are on the way to introduce a number of Biosimilar monoclonal antibodies in Bangladesh. As many of the monoclonal antibodies are losing patent right in the recent years we are hopeful that it will be possible to bring Biosimilar mAbs within the affordability of the vast majority population of the world.
The biotech facility of Ziska has been designed as per recommendation of USD-FDA and has been equipped with 100% European equipments. A group of experienced biotechnologist and pharmacists are engaged in the development and manufacturing of biotech products. As given almost any substance, it is possible to produce monoclonal antibodies that specifically bind to that substance, our slogan for biotech project is “Nothing Impossible”