What Are Synthetic Biologics & How Are They Used?

Biologics are complex medicines derived from living cells or organisms, used to treat a wide range of diseases including cancer and autoimmune disorders. Synthetic biologics involve designing and constructing new biological systems, or redesigning existing ones, to produce novel functions. This field, synthetic biology, combines principles from biology, engineering, and computer science to create engineered biological entities. These engineered systems can range from genetic circuits and biological pathways to entire organisms.

Understanding Synthetic Biologics

Synthetic biologics are distinct from naturally derived biologics and traditional small-molecule drugs due to their engineered nature and often novel structures. Unlike small-molecule drugs, which are typically chemically synthesized compounds with low molecular weight, synthetic biologics are large, complex molecules derived from living systems. Small molecules can often be taken orally, but biologics, including synthetic ones, are much larger, often containing thousands of atoms, and usually require injectable or infusible delivery methods as they would break down in the digestive system.

Naturally derived biologics are extracted from living organisms. Synthetic biologics, however, are specifically designed and constructed, rather than simply isolated. This allows for precise design and targeted function, often resulting in structures or capabilities not found in nature. They are designed to interact with biological systems in highly specific ways, aiming for targeted treatment options with potentially fewer off-target effects.

The Engineering Behind Synthetic Biologics

The creation of synthetic biologics involves meticulous design and construction using advanced engineering principles. This process begins with rational design, where scientists conceptualize a desired biological function or outcome. They then utilize genetic engineering and genome editing tools to modify existing biological systems or to build new ones from scratch. This can involve inserting long stretches of DNA into an organism’s genome or making precise, smaller changes to existing DNA.

Advanced manufacturing techniques, often utilizing “cell factories,” are employed to produce these designed biologics. This involves developing new cell lines optimized for biologic production, including designing genetic circuits to enable the production of specific proteins or metabolites. Metabolic engineering can also be used to alter the metabolism of cells to produce specific compounds, such as therapeutic biologics. Bioprocess optimization, like fermentation, enhances the yield and efficiency of biologic production.

Diverse Applications of Synthetic Biologics

Synthetic biologics have diverse applications across multiple fields, including medicine, industrial biotechnology, and materials science. In medicine, they are revolutionizing therapeutics, diagnostics, and vaccine development. Engineered cells, for example, can be designed to produce specific proteins for targeting diseased cells, leading to personalized medicine approaches and cell-based therapies. Synthetic biology has contributed to the development of monoclonal antibodies like adalimumab (Humira) for autoimmune disorders, and recombinant human insulin for diabetes, produced using genetically engineered bacteria.

Beyond therapeutics, synthetic biologics are being used to create safer and more effective vaccines by weakening viruses at the genomic level. They also play a role in developing biosensors that can detect specific biomarkers and diseases at early stages, improving diagnostic capabilities. In industrial biotechnology, microorganisms are engineered to produce chemicals for various industries, such as a chemical used in rubber tire production that was previously derived from petroleum, offering sustainable alternatives to traditional materials.

Transforming Science and Medicine

The development of synthetic biologics is enabling new scientific discoveries and profoundly changing approaches to disease treatment. This field allows for the creation of biological systems with novel functionalities that do not exist in nature, pushing the boundaries of what is possible in biology. By designing gene circuits that can sense and correct genetic mutations, researchers are developing more precise treatments for genetic disorders. For instance, engineered T cells (CAR-T cells) are being used to recognize and attack cancer cells, offering targeted cancer therapies with fewer side effects.

Synthetic biology also opens up possibilities previously unattainable with traditional methods by overcoming limitations of conventional therapies. It facilitates the artificial production of numerous drugs using biological cell factories, providing novel avenues for drug synthesis. This includes integrating heterologous pathways into designer cells to efficiently produce medical agents and enhancing yields of natural products in cell growth media. The ability to engineer living systems is accelerating drug discovery, potentially reducing development costs and increasing access to effective and affordable treatments.

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