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Advances in the life sciences continue to deliver
significant benefits to society across a broad spectrum
of application areas, ranging from health products
to sustainable materials. Rapidly advancing technologies and
deepening understanding are now generating the potential to
deliver increasingly effective and beneficial solutions, such as
targeted diagnostics (including infection and disease monitors),
personalised therapies, and speciality chemicals from a range of
sustainable feedstocks. Synthesis — a mainstay of the chemical
industry for nearly two centuries and currently enabling the
production of tens of thousands of useful chemicals ranging
from aspirin to Lycra — plays an increasingly important role
in supporting these advances. For example, whereas insulin
extracted from the pancreas of pigs was originally found to be
an effective therapy for diabetes nearly a century ago, since the
early 1980s the large-scale synthesis of genetically modified
forms of insulin and its analogues now enables the delivery of
more effective and affordable treatments.
Synthetic biology represents a leading edge in our
understanding of the relationship between molecular structure
and function at the genomic level. This capacity stems from
rapid developments since the beginning of the twenty-first
century in high-throughput, low-cost data-analysis techniques
such as DNA sequencing, combined with remarkable advances
in computational power and data handling, and the field
continues to assimilate new tools and techniques. This builds
on more than forty years of complementary and contributory
advances in the life sciences, with origins stemming back to
the discovery of the structure of DNA in 1953. Introducing
engineering design principles into the design–build–test cycle
can also enhance the predictability and robustness of these
innovations, and accelerate the development of more bespoke
and cost-effective solutions.
Yet the commercialization of effective solutions depends not
only on technological feasibility, but also on their affordability
and their social acceptability. To ensure that intended benefits
are delivered, it is important to recognize the existence and
significance of a wide range of stakeholder interests, societal as
well as technological, and to generate an environment in which
relevant issues can be identified and addressed transparently
and unambiguously. The UK government’s Synthetic Biology
Leadership Council provides a multi-stakeholder forum in
which such issues may be addressed.
What exactly is synthetic biology?
A clearly expressed and widely adopted technological
definition of synthetic biology was outlined in the Royal
Academy of Engineering report on synthetic biology 1 , and
in the UK Synthetic Biology Roadmap 2 : “Synthetic Biology is
the design and engineering of biologically-based parts, novel
devices and systems as well as the redesign of existing, natural
biological systems”. This highlights the key differentiator
between synthetic biology and other fields: the application
of systematic design through the implementation of the
engineering principles of standardization, characterization
and modularization. Adopting these principles allows for the
application of systems theory, control theory, signal processing
and a range of metrology techniques and standards. These
themes are reiterated in the European Commission’s recent
definition of synthetic biology 3 .
However, it cannot be overlooked that other definitions
exist and the term is sometimes applied more loosely, forming
a potential source of ambiguity. This partly reflects the evolving
nature of synthetic biology, the different interests and needs
of stakeholders, and the various purposes to which the term
is applied. Non-specialists may sometimes apply the term
‘synthetic biology’ as a shorthand descriptor covering a broad
range of leading edge bio-technological developments. But a
technical specialist, funding agency or regulator may require
a much sharper definition to be clear what is or is not being
considered in a particular context. Such diversity of language
is common to many technical fields and not peculiar to
synthetic biology. It is not therefore a significant issue, as long
as the purpose and context of any definition or description is
understood. Here, we adopt the definition expressed above as
representing the core characteristic of synthetic biology, and
supplement this definition with a clarification of its scope as
follows.
A key goal of synthetic biology is to translate innovative
concepts developed at a laboratory scale into potentially useful
and commercializable options. This is not simply a matter
of seeking uses for an emerging new technology. Market
pull — the need to develop effective solutions to ongoing
challenges — will often provide the inspiration and goal. These
activities enable the identification of a product or service
concept that will then have to be assessed against available
marketplace alternatives before committing to full-scale
commercial investment. Regulatory conformance is just one
of a wide range of checks and balances that will determine
whether a particular option ever reaches market. To scale
up into a robust and viable market product or service, many
other considerations ranging from process engineering and
economics to customer value assessment may need to be
taken into account. For example, pharmaceuticals will need
to pass clinical trials, speciality chemicals will need to meet
product performance specifications, and so on. In this context,
synthetic biology may often serve as an innovative frontend
to established market-facing sectors such as industrial
biotechnology, agri-tech and healthcare, each sector being
subject to its own specific, stringent regulatory frameworks
and marketplace dynamics.
Synthetic biology is essentially an enabling discipline. Meeting
the underlying objective of introducing engineering design
principles — by generating robust and reliable biological
parts, devices and systems — directly focuses attention onto
sources of uncertainty. Identifying and reducing those sources
of uncertainty is key to increasing predictability. In its current
early stage of development, this objective restricts synthetic
biology to the incorporation of a limited number of parts at
a time, but as we gain greater understanding of the complex
interactions and internal control mechanisms that occur
within biological systems, so the potential of the approach
will expand. Historically, the redesign of biological systems has
been a predominantly empirical ‘trial-and-error’ activity, but
the ongoing establishment of relevant standards and metrology
will facilitate the introduction of engineering-related design and