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By Donovan Swift
Jul 01, 2025
Gene-editing technology has been in the news lately thanks to the recently unveiled “dire wolf,” but the field of industrial biotechnology and synthetic biology stretches far beyond one pack of genetically modified wolf pups. The field encompasses everything from agriculture to the chemicals used in household cleaning products. I spoke with Joseph McAuliffe, chair of ASTM’s biotech committee and technical fellow at International Flavors & Fragrances (IFF), to help understand the current state of the industry and where it’s headed.
Industrial biotechnology is really an established set of industries. It covers a number of end products, for example: cleaning products and household and personal care products. Within the grain industry, you make ethanol using enzymes, which are products of biotechnology. A lot of food-processing aids are the result of industrial biotechnology. Really, it's an overarching term that includes many things that are non-medical in their end use and represents an important component of the global chemical value chain, one where we're trying to increase our penetration into the global chemical market by biological manufacturer of chemicals and materials.
In contrast, synthetic biology is a more recent term. It really emerged in the late 1990s or early 2000s, to describe an engineering philosophy where one tries to break living systems down into modules, kind of like a car, and then reassemble them to perform a desired function. So, in that sense, synthetic biology is a somewhat more academic discipline that focuses more on the front end of the research, but really the term is used more broadly now, almost as a synonym for industrial biotechnology. Some people would say it's a rebrand of genetic engineering. So, we refer to synthetic biology as an industry as well, even though the term began as more of an engineering philosophy.
First, I should explain our philosophy as a committee. Our observation that industrial biotechnology is not one but many industries — some of which are quite mature, like enzyme production — led to a strategic decision near the beginning of the committee, which was founded in 2014, whereby we decided to go for more strategic standards as opposed to tactical standards. And by that I mean strategic standards are aimed more at policymakers. This means, for example, trying to get their attention focused on an area that really needs better regulation. The use of genetically modified organisms in the environment is a good example of this.
Tactical standards, on the other hand, are more about methodology and test methods. We are doing that as well. But one of the challenges in tactical standards is that the science and the technology are changing quickly, and tactical standards can soon become obsolete. So, we've put most of our effort into a fairly narrow, restricted number of standards.
One of the bigger efforts is a standard classification for industrial microorganisms (E3214). This standard was approved in 2019 after about three years of development, and we're currently in the process of revising it. This standard is impactful — we hope — because it seeks to move the discussion about whether an organism is genetically modified or not beyond a simple yes or no answer, to what type. That is a very important question.
In addition to splitting the genotype class of a microorganism into four different categories, we also have additional fields to describe the trait, risk, safety, the use and mode of use, and also the degree to which that organism has been characterized by genetic sequencing, for example.
That's an example of a standard that we put an enormous amount of time into and about which we consulted many stakeholders both within our ASTM membership and beyond. And it has this overarching goal, which is to expand the debate and add the nuance that we feel is missing, so that all stakeholders, not just companies or their direct customers, have a better idea of what they're dealing with.
In addition, we've also spent a great deal of time on our terminology standard (E3072), which includes over 60 terms at this point. We focused on terms that we feel would support the technical standards we're trying to develop and also clarify again some of the misconceptions about use of terminology in this rapidly evolving field.
Currently we have two or three work items that would qualify as strategic-level standards where the standard is focused on policymakers, or the people financing the industry who may need a standard to get a better understanding of the risks involved.
For example, we're seeking to develop a standard (WK85971) based on existing standards from the Canadian Standards Association around defining the risk for biomass supply chains. This standard would be a list of things that the people should consider when they're trying to develop and finance biomass-driven operations. For example, an important consideration is where it might be best to locate the operation. That standard is actively being pursued and hopefully will be balloted this year.
In addition, another large effort is to develop a test method for carbon intensity (WK76263) to support a broader effort that extends beyond ASTM around a carbon-intensity label for consumer products. Our goal is to define a test method that would allow someone to quickly determine how much carbon was required to produce a product. This includes how much carbon it contains, how much was used to make it, and how much carbon, for example, remained in the ground if it's a product of agriculture.
In addition, we have other efforts around defining a set of guidelines for engineering microorganisms (WK84273) when you intend to use them in the open environment. The history of open release of genetically engineered microorganisms goes back to the 1980s, so there's quite some precedent for this. But there's also a history of controversy. And good standards can help the communication aspect and ideally avoid or help reduce controversy around what is admittedly a powerful technology that needs to be used wisely.
I was at an industry conference last week (SynBioBeta), and it seemed like every second talk was about artificial intelligence (AI). We are already seeing proven impact in protein design from AI, and I think that will extend to ever-more complex designs. AI will soon be able to predict phenotypes in more complex organisms and ultimately the ability to design phenotype from first principles, and before that, the ability to design enzymes completely de novowithout prior knowledge of other structure. Currently, AI is based mostly on correlation. You have a big database of known outcomes, so it makes it easier to predict something that is still related. But I think AI will evolve beyond just those correlation-based algorithms to ones that draw on other types of information, calculation, etc. The ability to simulate and model biological systems and engineer them will increase quite substantially in coming decades, and I think that will be very impactful.
Also, the ability to read and write DNA has already had a very big impact on the field. The cost of reading and writing DNA has fallen immensely, at an even greater rate than many would have predicted. Things are becoming dramatically cheaper, and that will continue to have an impact on the rate at which we can engineer biology.
That said, there are likely to be some impediments to, for example, developing chemicals and materials biologically versus the traditional approaches through petrochemical means, because there's an existing and mostly depreciated infrastructure to make petrochemicals. Oil is a much more amenable substrate to chemical modification than biomass.
So there are some inherent challenges that I think the industry will still be facing for quite some time.
I began as a synthetic carbohydrate chemist, and my original career ambition was to become an academic, likely moving back to Australia, which is where I'm originally from. However, I had a wonderful opportunity doing a postdoc in Edmonton, Alberta, Canada. I then moved from that location, still in the same postdoc, to San Diego and worked essentially as a chemist in a sea of biologists. And that set me up for a job that I still have 25 years after joining a company called Genencor, which was one of the pioneers in industrial biotechnology, having spun off from Genentech in 1982.
So I abandoned my career goal to become an academic because I saw just how amazing the world of industrial biotechnology was. Seeing that industry is far more dynamic than I had thought from an academic perspective and being able to work on more and different types of scientific problems than I ever would have as an academic made me realize how lucky I was to be given the opportunity by my postdoc advisor, Ole Hindsgaul, to use my skills as a chemist in biological research.
Currently, I'm a technical fellow at IFF, with responsibilities around analytical science, carbohydrate chemistry, and anything where a chemist can offer some value in an otherwise biology-focused company.
Joseph C. McAuliffe, Ph.D., is a technical fellow at IFF (formerly Genencor/DuPont) based in Palo Alto, California. He holds a Ph.D. in synthetic carbohydrate chemistry from the University of Western Australia and conducted postdoctoral work at the University of Alberta and Sanford Burnham Institute. McAuliffe is the author of 32 scientific papers, four reviews, four book chapters, and 46 granted U.S. patents. He has over 25 years of industry experience in industrial biotechnology and was a member of the teams that developed biological processes for production of 1,3-propanediol and BioIsoprene™ monomer. His current research interests include analytical and materials science, metabolomics/proteomics, sensor technologies, and biocatalysis. McAuliffe is also the chair of ASTM’s committee on industrial biotechnology and synthetic biology (E62).
July / August 2025