The 80 scientists and engineers that comprise the consortium believe synthetic biology can address key challenges in health and medicine, but technical hurdles remain

Synthetic biology now has a 20-year development roadmap. Many predict this fast-moving field of science will deliver valuable products that can be used in diagnostics—including clinical laboratory tests, therapeutics, and other healthcare products.

Eighty scientists from universities and companies around the world that comprise the Engineering Biology Research Consortium (EBRC) recently published the 20-year roadmap. They designed it to “provide researchers and other stakeholders (including government funders)” with what they hope will be “a go-to resource for engineering/synthetic biology research and related endeavors,” states the EBRC Roadmap website.

The EBRC is “a public-private partnership partially funded by the National Science Foundation and centered at the University of California, Berkeley,” a Berkeley news release states.

Medical laboratories and clinical pathologists may soon have new tools and therapies for targeting specific diseases. The EBRC defines synthetic biology as “the design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems. Synthetic biology builds on the advances in molecular, cell, and systems biology and seeks to transform biology in the same way that synthesis transformed chemistry and integrated circuit design transformed computing.”

Synthetic biology is an expanding field and there are predictions that it may produce research findings that can be adapted for use in clinical pathology diagnostics and treatment for chronic diseases, such as cancer.

Another goal of the roadmap is to encourage federal government funding for synthetic biology.

“The question for government is: If all of these avenues are now open for biotechnology development, how does the US stay ahead in those developments as a country?” said Douglas Friedman, EBRC’s Executive Director, in a news release. “This field has the ability to be truly impactful for society and we need to identify engineering biology as a national priority, organize around that national priority, and take action based on it.”

Designing or Redesigning Life Forms for Specific Applications

Synthetic biology is an interdisciplinary field that combines elements of engineering, biology, chemistry, and computer science. It enables the design and construction of new life forms—or redesign of existing ones—for a multitude of applications in medicine and other fields.

Dark Daily reported on one such breakthrough by researchers in Cambridge, England, that involved the creation of synthetic E. coli. They were studying the potential use of synthetic genomics in clinical laboratory medicine. (See, “Scientists in United Kingdom Manipulate DNA to Create a Synthetic Bacteria That Could Be Immune to Infections,” September 27, 2019.)

Another recent example comes from the Wyss Institute at Harvard. Scientist there developed a direct-to-consumer molecular diagnostics platform called INSPECTR that, they say, uses programmable synthetic biosensors to detect infectious pathogens or host cells.

The Wyss Institute says on its website that the platform can be packaged as a low-cost, direct-to-consumer test similar to a home pregnancy test. “This novel approach combines the specificity, rapid development, and broad applicability of a molecular diagnostic with the low-cost, stability, and direct-to-consumer applicability of lateral flow immunoassays.”

In March, Harvard announced that it had licensed the technology to Sherlock Biosciences.

Howard Salis, PhD (above), Associate Professor of biological engineering and chemical engineering at Pennsylvania State University (Penn State), co-chaired the EBRC Roadmapping Working Group that produced the roadmap. In a Penn State news story, Salis explained synthetic biology’s potential. “There are both traditional and startup companies leveraging synthetic biology technologies to develop novel biotech products,” he said. “Organisms that produce biorenewable materials; diagnostics to detect the Zika virus, Ebola and tuberculosis; and soil bacteria that fix nitrogen into ammonia for improved plant growth.” (Photo copyright: Twitter.)

Fundamental Challenges with Synthetic Biology

The proponents of synthetic biology hope to make it easier to design and build these systems, in much the same way computer engineers design integrated circuits and processors. The EBRC Roadmap may help scientist worldwide achieve this goal.

However, in “What is Synthetic/Engineering Biology?” the EBRC also identifies the fundamental challenges facing the field. Namely, the complexity and unpredictability inherent in biology, and a limited understanding of how biological components interact.

The EBRC roadmap report, “Engineering Biology: A Research Roadmap for the Next-Generation Bioeconomy,” covers five categories of applications:

Health and medicine are of primary interest to pathologists.

Synthetic Biology in Health and Medicine

The Health and Medicine section of the report identifies four broad societal challenges that the EBRC believes can be addressed by synthetic biology. For each, the report specifies engineering biology objectives, including efforts to develop new diagnostic technologies. They include:

  • Existing and emerging infectious diseases: Objectives include development of tools for treating infections, improving immunity, reducing dependence on antibiotics, and diagnosing antimicrobial-resistant infections. The authors also foresee tools for rapid characterization and response to “known and unknown pathogens in real time at population scales.”
  • Non-communicable diseases and disorders, including cancer, heart disease, and diabetes: Objectives include development of biosensors that will measure metabolites and other biomolecules in vivo. Also: tools for identifying patient-specific drugs; tools for delivering gene therapies; and genetic circuits that will foster tissue formation and repair.
  • Environmental health threats, such as toxins, pollution, and injury: Objectives include systems that will integrate wearable tech with living cells, improve interaction with prosthetics, prevent rejection of transplanted organs, and detect and repair of biochemical damage.
  • Healthcare access and personalized medicine: The authors believe that synthetic biology can enable personalized treatments and make new therapies more affordable.

Technical Themes

In addition to these applications, the report identifies four “technical themes,” broad categories of technology that will spur the advancement of synthetic biology:

  • Gene editing, synthesis, and assembly: This refers to tools for producing chromosomal DNA and engineering whole genomes.
  • Biomolecule, pathway, and circuit engineering: This “focuses on the importance, challenges, and goals of engineering individual biomolecules themselves to have expanded or new functions,” the roadmap states. This theme also covers efforts to combine biological components, both natural and non-natural, into larger, more-complex systems.
  • Host and consortia engineering: This “spans the development of cell-free systems, synthetic cells, single-cell organisms, multicellular tissues and whole organisms, and microbial consortia and biomes,” the roadmap states.
  • Data Integration, modeling, and automation: This refers to the ability to apply engineering principles of Design, Build, Test and Learn to synthetic biology.

The roadmap also describes the current state of each technology and projects likely milestones at two, five, 10, and 20 years into the future. The 2- and 5-year milestones are based on “current or recently implemented funding programs, as well as existing infrastructure and facilities resources,” the report says.

The longer-term milestones are more ambitious and may require “significant technical advancements and/or increased funding and resources and new and improved infrastructure.”

Synthetic biology is a significant technology that could bring about major changes in clinical pathology diagnostics and treatments. It’s well worth watching.

—Stephen Beale

Related Information:

Engineering Biology: A Research Roadmap for the Next-Generation Bioeconomy

What Is Synthetic/Engineering Biology?

Scientists Chart Course Toward A New World of Synthetic Biology

INSPECTR: A Synthetic Biology-Based Molecular Diagnostics Platform to Empower Patients and Consumers with Low-Cost, Self-Diagnostic Tests

Penn State Professor Co-Chairs Roadmap to Guide Synthetic Biology Investments

Scientists in United Kingdom Manipulate DNA to Create a Synthetic Bacteria That Could Be Immune to Infections