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Who’s Who in Plant-Made Pharmaceuticals

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Iowa State University – As part of the “Biotechnology Information Series,” the Iowa State University Web site contains background information on PMPs.  Topics explored include production alternatives, commercialization issues, regulatory and ethical issues, other information sources.

The National Science Foundation – The National Science Foundation (NSF), a U.S. government agency whose mission is to “promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense,” provides a primer on plant-made pharmaceuticals (PMPs).

Pharma-Planta Consortium – The Pharma-Planta Project is a consortium of 39 principal scientists from academic and industrial institutions in Europe and South Africa. Pharma-Planta is funded for 5 years, by the European Commission as part of the Sixth Framework Programme in the area of “Plant platforms for immunotherapeutic biomolecule production.”

Purdue University – Purdue University is working in collaboration with Controlled Pharming Ventures, LLC., to develop an enclosed PMP production facility in a converted limestone mine factory in Southern Indiana.  Part of this project involves the determination of light level optimization for the growth of PMPs. Read more →

Therapeutic Applications of Plant-Made Pharmaceuticals

Written by Margaret Bingu No comments yet

Plant-made pharmaceuticals (PMPs) hold great promise for helping produce and potentially enable new ways to treat a wide range of diseases and conditions, including cancer, arthritis and cystic fibrosis. PMPs are in various stages of development for use in the production of existing as well as new treatments for a range of therapeutic needs.

The potential benefits of using plants to produce therapeutic agents over other methods, such as genetically modified animals or conventional mammalian cell-based bioreactor production, include lower production costs, increased and more easily scaleable production capacity and lower risks of animal prion or virus transfer.

There are a number of PMPs in field or clinical trials today. It is likely that full-scale production and commercialization of some PMPs will be seen in the near future, while others are still several years away.

Some of the potential therapeutic applications for PMPs being explored today include:

Cancer Vaccines – Large Scale Biology (LSBC) is using Geneware (a process used to test the function of encoded novel genes and proteins, and manufacture bulk quantities of the complex proteins) to manufacture personalized vaccines for use in cancer treatment. These vaccines will be customized to the characteristics of each individual patient’s cancer, and made using genetic information obtained from cancer cells taken from the patient. Using Geneware, large quantities of patient-specific vaccine can be produced and purified within a matter of weeks.

Cancer Treatment – Under the terms of a partnership agreement between Dow Chemical Company and Sunol Molecular Corp., Dow will express in plants, an anti-tissue factor antibody developed by Sunol for treatment of multiple types of cancer. The research will focus on glycosylation, in vivo testing, and effector function. Knowledge gained from the work is expected to demonstrate the utility of plant production for injectable biopharmaceuticals.

Gastrointestinal Health, Iron Deficiency, Topical and Fungal Infections – Ventria Bioscience has been working on a method for the production of lactoferrin and lysozyme.  Lactoferrin and lysozyme are proteins found in human breast milk as well as most epithelial surface secretions including tears, nasogastric, saliva, and bronchial. Lactoferrin and lysozyme play a number of important roles in human physiology and a wide variety of potential products could be pursued through their development. Some of these include: gastrointestinal health; management of acute diarrhea; treatment and prevention of iron deficiency; providing iron delivery for infant nutrition; iron supplementation for adults; treatment of topical infections and inflammations; and alleviation of fungal infections.

Cystic Fibrosis and Exocrin Pancreatic Insufficiency – An absence of lipase prevents the body from being able to digest food lipids, leading to a condition known as steatorrhea. This condition is seen in patients suffering from exocrin pancreatic insufficiency and Cystic fibrosis. Cystic fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States. A defective gene causes the body to produce an abnormally thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections. Currently, the only way to acquire lipase is from cattle or pig glands, or through expensive laboratory processes. Meristem Therapeutics has been working on a way to produce lipase in a manner that is 14 times cheaper than conventional methods.

Traveler’s Diarrhea – ProdiGene, Inc. has been working in cooperation with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, studying the safety and immunogenicity of an oral vaccine against Traveler’s Diarrhea, a condition caused by enterotoxigenic E. coli.

Other potential uses – Ultimately, plant-made pharmaceuticals will be able to produce treatments for a wide array of conditions such as cancer, HIV, heart disease, chronic obstructive pulmonary disease (COPD), diabetes, Alzheimer’s disease, kidney disease, Crohn’s disease, cystic fibrosis, multiple sclerosis, spinal cord injuries, Hepatitis C, obesity, rheumatoid arthritis, iron deficiency and many others. In addition, recently published research suggests that some day plants may be used to help produce a safe, low-cost and limitless supply of human blood products.

Production Alternatives

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Scientists are exploring other options for the production of therapeutic proteins. Some of these include:

Animal Pharming
Animal pharming describes the process of using transgenic animals to produce proteins that are used in pharmaceutical production. This process involves the splicing and insertion of a foreign gene into the chromosome of a particular animal.  The protein encoded by the transgenic is secreted into the animal’s milk, eggs or blood, and extracted, refined, and used as the active pharmaceutical ingredient (API) in a pharmaceutical application.

International Academy of Life Sciences

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IALS is the place people come to for education, training and research in key issues relating to the life sciences. IALS provides a compass through innovative integration across the disciplines of life sciences, law, management and technology.

IALS is an international network with members across the globe. Each member represents another network (universities, institutions, organizations). IALS also works in public-private-partnership with GBM Association for Innovation and Technology Transfer Biomedicine Ltd.

Introduction to Plant-Made Pharmaceuticals

Written by Margaret Bingu No comments yet

New discoveries involving therapeutic proteins, such as monoclonal antibodies to treat various types of cancer, offer exciting and promising hope for a range of diseases.  However, there are challenges to producing these therapeutic proteins safely, economically, and in quantities that can be adjusted to meet growing  needs.  Current production methods include reproducing the target protein through cell culture or bio-fermentation processes; expressing the protein in genetically altered animals, or growing the proteins in plants also modified using modern biotechnology.

Current Production Challenges

Conventional cell culture methods require significant amounts of both time and money, and their ability to produce the complex molecules that are central to pharmaceutical treatments for many  diseases is limited.  It is estimated that cell culture manufacturing facilities cost between $250 million and $450 million and have construction times in excess of 3 years. Furthermore, they must be individually approved and certified by the Food and Drug Administration before full-scale operations can commence. Animal production challenges include the need to manage virus- and prion-transfer risks. Plant-based production, meanwhile, requires implementing current good-manufacturing laboratory-practice standards (cGMP) for containment.

Today, with 30 protein-based medicines on the market and close to 100 in late-stage human trials, there is a need to provide a range of options for production of the simple and complex molecules that are the backbone of these medical treatments.

The promise of PMPs

Plant-made pharmaceutical production may be one solution to the need to manufacture proteins for these medicines in a manner that is easily scaleable, safe and cost-effective. In this process, plants become factories that manufacture therapeutic proteins. These proteins are then extracted, refined, and used as the active ingredient in a pharmaceutical application.

In comparison with conventional production methods this process could save substantial amounts of time and money, enable more-easily scaleable production, and provide  the ability to produce  complex proteins that current systems. may not be able to produce.

Plants on Prescription

Written by Margaret Bingu No comments yet

WIESBADEN – Tobacco has a bright future – not in cigarettes, but as a pharmaceutical production factory for anti-cavities medicine. The US company Planet Biotechnology is using transgenic tobacco plants to cultivate the human protein CaroRx, which could prevent tooth decay in the future.

Tobacco plants are the basis for new medicines. The cultivation of active and additional substances in plants – the so called “molecular farming” – was the topic of discussion among medical practitioners at this year’s Intern Congress in Wiesbaden. For the first time in this country, attention was not focused on the risks of green biotechnology, but rather on its medicinal possibilities.

“CaroRx was the first active substance clinically tested on patients with promising success and no side effects so far,” said Eva Stoeger of the University of Aachen.

Scientists at St. George Hospital London were in charge of the development of the anti-cavity agent, but both Stoeger’s group and the Fraunhofer Institue for molecular biology and applied ecology in Aachen contributed to the project decisively.

Cavities, or tooth decay, is caused by a bacterium, called Streptococcus mutans. It adheres to enamel proteins by means of small protein antennas and processes food sugars into milk acid, which in turn attacks the enamel. CaroRx recognizes these antennas and blocks them “making it impossible for bacteria to dock onto the tooth,” said Eva Stoeger.

Safe and Cheap Bio-Factories

Fighting diseases with biologically active proteins is a well-known strategy. Market leaders such as Genentech or Chiron produce so-called biologicals for the treatment of rheumatism or multiple sclerosis, but their production makes use of transgenic microorganisms, or mammalian cells, rather than tobacco plants.

The problem with using microorganisms is that bacteria deliver the proteins in the form of useless clumps and mammalian cells need to be tested for pathogens that could possibly infect humans. Plants, acting as pharmaceutical factories, are much more economical and flexible, according to the opinion of experts such as Val Glidinger, American Biotechnology Association’s vice president for nutrition and agriculture.

“It’s important to optimize the technical filtering of the proteins from the plants,” said Eva Stoeger. “Guidelines for production will have to be developed, that would have to be valid for traditional pharmaceutical companies, as well. If these obstacles are overcome, plants will turn out to be promising, safe and economical bio-factories,” said Stoeger.

This attitude is greeted with doubt by biotechnology experts in Germany. “The most important thing with therapeutically used proteins is that they have to be constructed and folded precisely,” said Ludger Wess from the information service Biocentury.

“This process is not carried out in identical ways in plants and humans. It is not clear if plants always produce the active substances in the same way and in the same amounts. The vaccine-banana, or the cloned sheep Tracy, that produces an active substance against pulmonary congestion in its milk failed on exactly these accounts,” said Wess.

Promising cavity-prohibiting tobacco tincture

The study results for the anti-cavity tobacco plant agent are nevertheless promising. Dentistry students who applied it at the beginning of the study were cavity-free for one year. For it to be allowed on the market, it will need to prove effective in a phase 3 study with a larger number of patients.

The suspicion toward genetically modified plants is widespread in Europe. It was only a short while ago that the German government passed a law regarding genetic engineering. Many biotechnologists think this law is an effort to stifle their research, as it allows institutes and farmers who sow genetically manipulated seeds to be sued if a neighboring field is contaminated by windborne transgenic pollen by more than 0,9 percent—for most, an incalculable risk. At the same time, the European Union is supporting a new project to develop vaccines against rabies, tuberculosis, diabetes and HIV from plants. The first tests with these medications are expected in 2009.

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