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The pharmaceutical industry is undergoing remarkable changes with the discovery and introduction of biotech drugs. Biotech drugs are medicines that are therapeutic proteins, such as monoclonal antibodies, blood proteins and enzymes, that are produced by living organisms to fight disease. Unlike other medicines, they are not synthetically produced, but are usually produced through microbial fermentation or by mammalian cell culture. They are also more difficult, time-consuming and expensive (at least $250 million in production facilities costs alone) to produce than synthetic drugs. Financial analyst U.S. Bancorp Piper Jaffray reported in 2002 that the cost of materials for biotech manufacturing is 20 to 100 times that of synthetic drugs.
Today, there are more than 371 new biotechnology medicines in the pipeline. Cell cultures are grown in large stainless-steel fermentation vats under strictly maintained and regulated conditions. In some cases the proteins are secreted by the cells; in other cases the cells must be broken open so the protein can be extracted and purified.
Making a biotech drug
Producing biotech drugs is a complicated and time-consuming process. Many years can be spent in just identifying the therapeutic protein, determining its gene sequence and working out a process to make the molecules using biotechnology.
Once the method is devised and scaled up, the biotech medicines can be produced in large batches. This is done by growing host cells that have been transformed to contain the gene of interest in carefully controlled conditions in large stainless-steel tanks. The cells are kept alive and stimulated to produce the target proteins through precise culture conditions that include a balance of temperature (which can often vary by no more than one degree Celsius), oxygen, acidity (if pH levels change by even a small fraction, cells can easily die) and other variables. After careful culture (the duration varies depending on the protein produced and the nature of the organism), the proteins are isolated from the cultures, stringently tested at every step of purification, and formulated into pharmaceutically-active products. All of these procedures are in strict compliance with Food and Drug Administration (FDA) regulations.
Cost challenges to current manufacturing practices.
Traditional cell culture methods require significant capital and labor investment. Cell culture facilities, which take, on average, three to five years to construct, cost $250 million to $450 million to construct and must be individually approved and certified by the FDA prior to full-scale operation. Companies can spend at least $250 million in facility costs before pharmaceuticals have even entered Phase I clinical trials.
Supply challenges to current manufacturing practices
Because producing therapeutic proteins through currently available biotechnology culture methods can take several years, there are significant supply challenges. Further, it can be cost prohibitive to create additional manufacturing facilities on line to meet unanticipated demand. It is very expensive to maintain consistency in the manufacture and formulation of complex biotechnology medicines.
Today, current manufacturing practices are facing a major global capacity shortage for the production of biotechnology medicines. Worldwide, there are fewer than two dozen facilities capable of large-scale biotech manufacturing; thus, the biotechnology industry faces a worldwide factory shortage.
Furthermore, the capacity challenge is also expected to become more complex over the next decade. Today, there are only 30 protein-based medicines on the market and they already are outstripping the industry's production capacity. With a good portion of the 99 protein-based medicines now in late-stage human trials expected to hit the market soon, the limited production facilities will be overextended or constrained further in the years ahead. Additionally, with a growing aging population with chronic diseases, there will be a heightened demand for many protein-based medicines. Analysts with J.P. Morgan predict by 2005 the industry will need about four times the capacity it has now.
Using only traditional cell culture methods cannot produce sufficient quantities of therapeutic proteins to meet patient population needs without substantial and timely investment.
A new solution for pharmaceutical production challenges?
It is possible that the active ingredient in many protein medicines currently on the market or in the pipeline can be produced in crop plants more efficiently and economically than by using current microbial or cell culture technologies. This new field of "plant-made pharmaceuticals" (PMPs) may be able to successfully address the cost and potential supply challenges faced by current pharmaceutical production practices. Some analysts believe that this is especially true for monoclonal antibodies.
What are plant-made pharmaceuticals?
Plant-made pharmaceuticals (PMPs) are the result of the application of biotechnology to create genetically enhanced plants to produce therapeutic proteins. In this process, plants themselves become "factories" that manufacture therapeutic proteins. These proteins are then extracted, refined and used as the active pharmaceutical ingredient (API) in many medicines.
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