“Biopharming” in Plants – a Future Method of Biopharmaceutical Production?

Published: 29 Sep 2004

By Phil Webster, Pharma-Biotech Analyst, Europe

 

Introduction

Plant molecular farming, or “biopharming”, refers to a new area of science that combines the use of biotechnology and agricultural plants in order to produce valuable products. These may include Plant Made Pharmaceuticals (PMPs), or Plant Made Biologics (PMBs) such as vaccines and human proteins. Plant molecular farming uses the fact that plants have the natural ability to make human and animal proteins. These can be expressed by means of genetic engineering (GE) to induce a transgenic plant to express a specific target protein. This expression can be targeted to a specific plant tissue, facilitating simple harvesting and safe and consistent expression. Potential products include the development of antigens for vaccines that might be mass-produced in plants such as corn and used to fight such diseases as cancer and diabetes.

 

Analysis of Opportunities

Molecular farming is potentially big business. The Canadian Food Inspection Agency (CFIA), said in a recent report that U.S. demand alone for biotech pharmaceuticals is expanding at 13 percent annually and is expected to command a market value of $28.6 billion by 2004.

 

This huge future demand will put considerable strain on existing microbial and mammalian cell bioreactor systems. Concerns have arisen that production capacity may not meet demand, and that production costs for mass production are prohibitive. Growing plants as a medium to produce PMPs and PMBs has the potential to offer a solution to this problem.

 

Plant molecular farming can be used as a means of mass production by simply growing larger areas of crops relative to demand. This means that mass production of high value-added useful proteins can be done at very low cost. Generally production costs can be reduced to just 3.3% the cost of using animal cell culture and 33% of the cost compared to microbial culture systems. Conventional farming machinery and farming practices can be used in the crop production process to make production costs even lower.

 

Products produced in plants can be stored for long periods without refrigeration if they are expressed in seeds or leaves that can be stored dried. Furthermore, molecular farming has the potential to offer high levels of safety due to a low contamination risk from animal viruses and proteins. Therefore, medical proteins, industrial enzymes, and even cosmetic and functional food items can be produced safely and economically under controlled conditions.

 

Major challenges

The biggest challenge in plant molecular farming is a negative public perception towards GM crops, owing predominantly to safety concerns relevant to human health and to the environment. There is perception that food safety may be compromised and that GE crops may have an adverse effect on human health. From an environmental perspective, concerns over non-target impacts of GE crops as well as gene transgression to other plants and unrelated species may have undesirable impact. Thus far, no scientific has been published indicating that currently commercialised GE crops have a negative effect, but further scientific investigation is required for each individual case. 

 

A second major challenge is from a regulatory perspective. In this new and emerging area, no international guidelines are currently available. GE crops have been strongly opposed by some countries, with an unofficial moratorium in Europe. However, this perception is expected to change, as exhibited by the recent decision of Spain and Germany to resume small-scale GM field trials and production.

 

Market Leaders

A major leader in the area of molecular farming is Dow Plant Biopharmaceuticals, which specialises in antibody production from plants. The company is using its knowledge of the pharmaceutical industry and applying it through novel expression systems with industrial partners. Recent collaborators include Nobex Corporation, with whom Dow Plant Biopharmaceuticals are working with to develop an appetite anti-suppressant using a proprietary gene sequence in combination with the Dow Plant Biopharmaceuticals protein expression system in order to expand the company’s product portfolio. 

 

A second major player, ProdiGene Inc. is the first company to successfully market a PMB by producing recombinant trypsin in plants. Focusing more on large-scale recombinant protein manufacture in plants, ProdiGene Inc. is now looking towards the production of therapeutic proteins such as Aprotinin, a human therapeutic protein that is commonly used to control blood loss during surgery.

 

Summary

Plant molecular farming has the potential to be a major new method for the low cost mass production of biologicals and biopharmaceuticals. However, there are still major challenges to be overcome, including strong public opposition and poorly defined regulatory issues.

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