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Plants as a pharmaceutical source
Since ancient times plants have served as a natural source of treatments and therapies such as aspirin, quinine, and coffee. Today, scientists are using these renewable resources to produce a new generation of therapeutic solutions. Plants improved through the use of biotechnology can produce the essential proteins for innovative treatments for diseases such as cancer, HIV, heart disease, diabetes, Alzheimer's disease, kidney disease, Crohn's disease, cystic fibrosis, multiple sclerosis, spinal cord injuries, Hepatitis C, chronic obstructive pulmonary disorder (COPD), obesity, arthritis and iron deficiency.
Consumer benefits of plant-made pharmaceuticals
Traditional methods of producing pharmaceutical materials using microbial fermentation or animal cells are limited by the time and money necessary to build the required manufacturing facilities, and production is limited to manufacturing capacity. It can take a total of five to seven years from laying the first bricks of a traditional biotech facility to extracting pharmaceutical proteins from cultivated cells.
In many cases, it will cost significantly less to grow plants with the ability to mass-produce pharmaceutical proteins because plant-based techniques don't require the same costly capital investments.
Plant-made pharmarceutical production can also be more easily expanded to provide larger quantities if demand for the drug increases. Additionally, because plants are renewable in nature and can produce pharmaceutical proteins within a single growing season, production can be quickly scaled up to meet patient needs.
Production and cost advantages of plant-made pharmaceuticals can allow more capital to be invested in research and development of new therapeutics, giving patients access to new drugs faster. In addition, expanded manufacturing capacity of high-quality proteins will spur development of more medicines by removing a key hurdle to mass production.
Futhermore, cultivating cells for protein production with traditional fermentation methods is complicated with many risks involved. Cells must be carefully monitored to ensure proper development and survival, and the alternate source, mammalian cells, are at risk for contamination and the potential transmission of animal-based pathogens and viruses. Pharmaceutical proteins produced in plants bypass many of the risks and concerns inherent to fermentation technology.
Bottom line: for certain types of pharmaceuticals, plant-based protein production is the most cost-effective method to provide patients and their primary care physicians with faster access to new drugs. Industry analysts expect this to be the case for monoclonal antibodies which are the largest growing class of therapeutic proteins.
Source: Alzheimer's Association, American Cancer Society, American Diabetes Association, American Heart, American Lung Association, American Obesity Association, Arthritis.com, Centers for Disease Control and Prevention, Cystic Fibrosis Foundation, ChrohnsResource.com, Lupus Foundation of America, National Kidney Foundation and the National Multiple Sclerosis Society.
Real life example: When demand exceeds capacity
Introduced in late 1998, Enbrel®, manufacturered by Immunex Corporation (which was
acquired by Amgen in July 2002), has proven to be one of the most successful biotechnology treatments ever.
A twice-weekly self-injectible medication, Enbrel® was designed to treat patients with moderate to severe rheumatoid arthritis, a painful joint inflammation that affects more than two million arthritis patients in the U.S. In 2002, Enbrel® was taken by 82,000 patients in the United States to treat rheumatoid arthritis.
Enbrel®, one of the new generation of biotech drugs, is a genetic copy of proteins that stop inflammation. These proteins are produced in cultured hamster cells that are stored in bioreactors. The results (two of three patients enjoy relief) have had patients clamoring for it and has created the most overwhelming supply shortage in pharmaceutical history. Despite a cost to patients of $1,000 to $1,200 per month, Enbrel® was so effective that it grew immensely popular among rheumatoid arthritis patients, and Immunex was faced with a supply shortage in early 2001.
By March 2002, there was a waiting list of 13,000 patients to receive the treatment. Immunex also was forced to create a distribution system designed to prevent hoarding and to maximize the number of patients who could receive the drug.
The source of the shortage? Enbrel® is a biotech drug manufactured in 10,000-liter tanks in sterile manufacturing facilities that cannot be built fast enough to keep up with patient demand. Pharmaceutical industry experts believe since it takes three to five years, and about $450 million to build a biotech facility, for Immunex to have been adequately prepared to meet the overwhelming patient demand, they would have had to have made that then-risky investment in 1997, before Enbrel® had even received FDA approval. Instead of investing the time and money in constructing its own facility without a prediction of the success of Enbrel®, Immunex partnered with a German biotechnology firm to produce the pharmaceutical proteins it needed. Ultimately, Immunex was not able to meet customer demand at that time.
Analysts predict that biotech drug shortages like this may become more common. This is just one example of why biotechnology firms are looking to plant-made pharmaceuticals to expedite patient access to new therapeutics.
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