Industrial Biotechnology

ASTM Organizes New Technical Committee

With a total population of nearly 7.2 billion people, and a new birth every eight seconds, our modest planet is straining at the seams. Finding ways to maximize the sustainability of the resources that support us all is of critical importance.

One such effort falls under the general heading of industrial biotechnology, which is based on a fascinating premise: that biobased materials (i.e., those made from either a biological, or living, source or from renewable sources such as corn, sugar cane or carbon dioxide/carbon monoxide gas streams) can be substituted for similar materials derived from fossil fuels. The benefit? More efficient, less environmentally harmful production of chemicals, plastics, drugs and other products critical to the quality of life we enjoy.

Subsequent to discussions with ASTM International that were initiated by the industry trade group SOCMA, the Society of Chemical Manufacturers and Affiliates, in early 2013 and followed by a series of exploratory meetings, ASTM’s board of directors recently approved the establishment of new ASTM Committee E62 on Industrial Biotechnology.

What Exactly Is Biotechnology?

Bread. Cheese. Beer. Sounds like the components of a nice snack, right? Indeed they are, but these common elements of our diet are also basic examples of biotechnology in action, and of the fact that the scientific foundation on which modern industrial biotechnology rests actually dates back thousands of years.

Yeast, a microscopic fungus, is added to bread dough to ferment carbohydrates in the flour, generating carbon dioxide gas that leavens the mixture. In a similar fashion, the fermentation process used to make beer is based on the reaction of yeast with sugars from barley (or other grains), producing carbon dioxide and alcohol. Rennet, an enzyme, is used to curdle milk as part of the cheese-making process.

Delicious, but an example more pertinent to the sophisticated implementation of biotechnology on an industrial scale is succinic acid. Originally obtained by pulverizing and distilling amber, succinic acid is employed in the food and beverage industry as an acidity regulator and food additive, and as a raw material for pigments, polyurethanes, adhesives and pharmaceuticals, among other products.

Companies such as Myriant and BioAmber are now using fermentation-based processes to produce bio-succinic acid. Chemical assay confirms that this biobased alternative is chemically identical to petroleum-based succinic acid, while life cycle analysis reveals that the production process requires less energy and generates significantly lower greenhouse gas emissions than traditional methods of producing the acid.

The website of the trade group BIO, the Biotechnology Industry Organization, defines biotechnology as “technology based on biology — biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet.” Rina Singh, BIO’s senior director, industrial and environmental sector, Washington, D.C., says, “Engineering microbes by inserting very specific DNA so that now the microbe eats whatever food we give it and generates the specific renewable chemicals we’re looking for — this is biotechnology in its purest form.”

From Evolved Biocatalysts to “Green” Paint

When confronted with the colors red, white and green, the first thing you may think of is Christmas, or perhaps — depending on your level of interest in opera and classic Ferraris — the Italian flag.

In the world of industrial biotechnology, however, these colors distinguish three distinct areas in which the discipline’s innovations are being put to the test. Red biotechnology refers to medical and pharmaceutical applications, white biotechnology to industrial uses and green to the development of agricultural products.

The need to address modern-day social and environmental imperatives is creating a ready audience for such endeavors. Singh cites the “red” example of sitagliptin, the active ingredient in a treatment for Type 2 diabetes. Given the dramatic and well-documented increase in the number of people suffering from this disease, devising more efficient ways of manufacturing therapeutic medications to address it is critically important.

Pharmaceutical firm Merck and Codexis, a BIO member company and provider of “enzyme optimization services,” collaborated to develop an environmentally friendly enzymatic process for manufacturing sitagliptin that, in Singh’s words, “mitigates some of the costs of production and reduces pollution and waste products.” In fact, according to the U.S. Environmental Protection Agency, which recognized the Merck/Codexis collaboration with a Presidential Green Chemistry Challenge Award in 2010, “the benefits of the new process include a 56 percent improvement in productivity with the existing equipment, a 10–13 percent overall increase in yield and a 19 percent reduction in overall waste generation.”

Merck was able to eliminate high pressure catalytic hydrogenation, a step in the manufacturing process that requires expensive equipment and the use of a rhodium catalyst, through the use of biocatalysts — enzymes engineered by Codexis specifically for that purpose. Early research suggests these biocatalysts may be applicable to the manufacturing of other drugs as well.

In the industrial sector, Benjamin Borns, staff chemist for Sherwin-Williams Global Supply Chain R&D, points to the company’s water-based alkyd acrylic technology (another Green Chemistry Challenge Award winner), an example of the replacement of nonrenewable inputs with biobased alternatives. “Using this technology, we make commercial paint products from soybean oil and recycled PET [polyethylene terephthalate, the plastic used in water bottles] that cut volatile organic compounds content by 60 percent,” Borns says.

Fossil Fuel Alternatives

Isoprene: used in the production of synthetic rubber. Polyester: synthetic polymer fiber well-known to leisure suit wearers. Polypropylene: common in food packaging and textiles.

All these materials, and others found in a staggering array of consumer and industrial products, including paint, are made from petroleum feedstocks. One of the most exciting aspects of biotechnology is its ability to reduce the use of fossil fuels by substituting renewable alternatives.

Take isoprene. It requires about seven gallons of crude oil to make one gallon of this colorless liquid. Working in partnership with Goodyear, DuPont developed the BioIsoprene monomer using a fermentation process involving genetically enhanced microorganisms and sugars derived from renewable resources. The companies are working on scaling up this process to a commercially viable level.

Examples like this are found across a wide swath of consumer and industrial markets. From biodegradable food and beverage packaging to enzymes found in many laundry detergents, products are either already available or are in the pipeline that epitomize the potential of biotechnology to reduce reliance on fossil fuels and the negative effects of that reliance on the environment and the global climate situation.

The Need for Standards

It is worth noting that standards related to certain aspects of industrial biotechnology are already in place. One of the most significant is ASTM D6866, Test Methods for Determining the Biobased Content of Solid, Liquid and Gaseous Samples Using Radiocarbon Analysis. Borns points out that this standard has been adopted by the U.S. Department of Agriculture’s BioPreferred program, which was established to promote the increased purchase and use of biobased products.

Larry Sloan, president and CEO of SOCMA, Washington, D.C., believes that new standards development activities to be carried out by members of ASTM Committee E62 will not only help strengthen the global “brand” of specific programs like BioPreferred, but also play a broader role in establishing a more consistent foundation on which to base industry-related incentives and regulations.

“Without industrial biotechnology standards, we cannot have good policy, and without good policy we cannot have investment. And, without investment, the U.S. cannot remain the global innovation leader that it is,” Sloan says.

Borns identifies a number of particular areas where the efforts of Committee E62 should bear fruit. “Standardization of nomenclature around biotechnology is a very big need,” he says. “There is often a lot of confusion when trying to talk to potential partners and customers about new technologies. Another issue that standards can help to clarify is that raw materials that are sourced from biotechnology operations are expected to have different sets of impurities than their petroleum-based analogs. Standardization on how to measure and report impurities in ‘drop-in’ biobased chemicals or how to define when a chemical is truly a drop-in alternative for a petrochemical is also needed.”

SOCMA’s Sloan echoes Borns’s point about terminology. “If we can have standards and definitions of what ‘renewable,’ or ‘biobased,’ or ‘sustainable,’ mean in the context of biotechnology, it reduces confusion in the marketplace so that there is a common and consistent lexicon for buyers to refer to,” he says.

Singh cites the role of standards in establishing protocols for identifying the crucial differences between fossil-based and biobased products, and in deciding which of the life cycle analysis methodologies currently in use should become the industry norm. “LCAs are a key tool in industrial biotech, covering the entire value chain,” Singh says. “Consensus in this area is very important.”

In fact, according to Singh, the need for stakeholder agreement on a variety of biotechnology-related issues is truly a global issue: “With some standards having already been defined in the U.S. even as the European Union looks to create its own, our hope is that establishing a consensus among key industry players around the world through ASTM — an international organization with very good outreach — will help avoid confusion caused by competing and contradictory standards.”

Pat Picariello, director, developmental operations at ASTM International, explains that one of the early agenda items for the members of Committee E62 will be to review existing standards to eliminate “duplication of effort scenarios.” The committee structure will include an executive subcommittee as well as task-oriented subcommittees on technology, test methods, best practices and liaison.

As with all such initiatives, the ASTM process is designed, in Picariello’s words, to “ensure that interested individuals and organizations representing academia, industry, product users and governments alike all have an equal vote in determining a standard’s content. The standards developed by this new activity will have the unique advantage of representing the needs of the global community.”

Coordinating Work

A number of existing ASTM International activities touch on the subject of biotechnology in the context of specific impacted product categories. Some of the current ASTM committees that Committee E62 on Industrial Biotechnology will coordinate with include the following:

  • D10 on Packaging
  • D14 on Adhesives
  • D20 on Plastics
  • E06 on Performance of Buildings
  • E44 on Solar, Geothermal and Other Alternative Energy Sources
  • E48 on Bioenergy and Industrial Chemicals from Biomass
  • E55 on Manufacture of Pharmaceutical Products
  • E56 on Nanotechnology
  • F01 on Electronics
  • F04 on Medical and Surgical Materials and Devices
  • F10 on Livestock, Meat and Poultry Evaluation Systems
Jack Maxwell is a freelance writer based in Westmont, New Jersey.

This article appears in the issue of Standardization News.