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How to Make Industrial Biotechnology Commercially Viable

Professor Keith Tyo co-authored a perspective in Science highlighting three areas that can be improved

Biotech

Biotechnology is changing our world for the better every day by synthesizing new chemicals for uses in medicine and materials. Because of the frequent strides forward in this field, the scope of what’s possible is constantly expanding. 

Keith Tyo

Yet these impressive gains haven’t translated to commercial success, which threatens to limit job growth and restrain how much society benefits from this important research. A policy forum piece published on December 23, 2021, in the academic journal Science co-written by Northwestern Engineering researchers addressed that issue to help the field take advantage of its benefits and how it’s suited for applications with favorable sustainability metrics.

The piece “Enabling Commercial Success of Industrial Biotechnology” was co-authored by Keith Tyo, associate professor of chemical and biological engineering, along with postdoctoral researcher Bradley Biggs. Other collaborators included University of Texas at Austin professor Hal Alper, University of Wisconsin-Madison professor Brian F. Pfleger, Christine Santos and Parayil Kumaran Ajikumar of Cambridge, Massachusetts-based biotechnology company Manus Bio, and MIT professor Gregory Stephanopoulos.
 
The three segments they identified are below:

1. Policy

One of the benefits of biotechnology is environmental sustainability, but the authors argue that the field is “undervalued” by society and regulators in favor of chemical processing. If that does not change, biotechnology will remain a niche that produces items that cannot be manufactured any other way.

The authors propose that any synthesis process should be required to “restore the environment to its original state, from before the synthesis process, including gases used and generated.”

“Requiring equal life-cycle impact for the two approaches could help balance competition between chemical and biological processes for high-volume chemicals while improving environmental conditions regardless of which approach is ultimately used,” the authors said. “Currently, more than 40 countries account for greenhouse gas emissions, as determined from life cycle analysis, to ensure that new, sustainable commercialization efforts are on a level playing field with mature, higher-emission businesses.”

Requiring equal life-cycle impact for the two approaches could help balance competition between chemical and biological processes for high-volume chemicals while improving environmental conditions regardless of which approach is ultimately used. 

Because biotechnology is still an emerging field, it can have trouble landing funding that helps translate academic discoveries into usable technology. However, the authors propose that this can be altered by tweaking existing funding methods. They also argue that restrictions on principal investigators from universities and labs should be loosened when it comes to earlier stages of technology transfer, with conflict-of-interest concerns being addressed by oversight.

In addition, they believe smaller-sized grants (around $1 million annually for five years) could “allow small interdisciplinary teams to function with more flexibility, higher accountability, and closer connection of principle investigators to the goals of the program.

“Further, such funding modifications would increase the necessity of translational research and commercialization and thus help create a culture of support and recognition for innovative solutions to critical bottlenecks in the practical application of new discoveries,” the authors wrote.

2. Infrastructure

A biomanufacturing process is not easy to create. It requires equipment tailored to the biocatalyst, or said biocatalyst could be squandered. The greatest need, according to the researchers, is “facilitated access to and use of pilot-scale fermentation facilities.” Pilot-scale facilities are essential for the risk-reduction process, and the lack of them has hampered growth of numerous products and contributed to the chasm between academic research and deployment.

Accurate scale-down systems allow the generation of datasets for testing numerous strain (genetic) variants under different conditions,” the paper states. “This approach is in contrast to most current datasets that screen many parameters or conditions, but for only a few strains. 

To help scientists close the gap, the article listed a series of US-based pilot-scale (approximately 100- to 20,000-liter units) facilities at universities and national laboratories in the United States.

The piece also discussed the current state of academic training, which is focused on biocatalyst development with minimal bioprocess optimization because of a lack of pilot-scale facilities. This restricts the growth of new minds and development of biocatalytics.

Conversely, the article also identifies a need for reliable scale-down methodologies and equipment. Current methods can produce plenty of microbial variants, but they must be evaluated in the right setting. Scale-down methodologies mimic aspects of commercial scale bioreactors without the expense or complexity.

“Accurate scale-down systems allow the generation of datasets for testing numerous strain (genetic) variants under different conditions,” the paper states. “This approach is in contrast to most current datasets that screen many parameters or conditions, but for only a few strains.”

3. Education

Biochemical engineering fundamentals aren’t taught as much now at many universities and have been swapped for a focus on emerging technologies. The authors contend that biochemical engineering is central to understanding cells, and that the shift is caused by a system that prioritizes novelty over problem solving.

Ultimately, to reap the potential benefits of industrial biotechnology, appreciation must be given to, and investments made in, the innovation and ingenuity required for translating to practice emerging scientific breakthroughs. 

“This is a serious issue that impairs the overall enterprise of industrial biotechnology because graduates lack experience and training to fill key positions, such as those involved in fermentation and scale up of downstream processes,” the authors said.

To alter this situation, the authors propose that academic institutions invest more in master’s programs that teach the basics of industrial biotechnology. The programs would emphasize solving open-ended design problems, preferably with inter-disciplinary teams. The training should also be different from pharmaceutical-centric training and the educational content determined by both academia and business.

Traditional research should also get more attention, and the reward system should recognize the importance of problem-solving instead of novelty.

“Ultimately, to reap the potential benefits of industrial biotechnology, appreciation must be given to, and investments made in, the innovation and ingenuity required for translating to practice emerging scientific breakthroughs,” the authors said.