Synthetic Biology in Pharmaceutical Industry
Synthetic biology is a multidisciplinary field that combines engineering principles with physics and molecular biology. It involves the modeling, design and construction of synthetic gene circuits, as well as other molecular elements that do not exist in nature. These biological components are then rewired and reprogrammed living cells or built cell-less systems with new functionalities for a wide range of applications.
The demands of medical and pharmaceutical applications have also driven the growth of synthetic biology. This includes the integration of heterologous pathways in designer cells to produce medical agents efficiently (Yan et al, 2023). New biocatalyst technologies are being developed for complex, high-chirality small molecules synthesis. Microbial factories are being built from the beginning to biosynthesis natural products from waste with greater efficiency. Highly diverse libraries of proteins are being precisely synthesized and optimized for in vitro or in vivo screening to speed up the discovery of biologic drugs (Bell et al, 2021).
It’s the big thing right now! The ability to run massively parallel workflows is now possible. Pharma companies have long known that the ability to leverage parallel workflows accelerates the time to market for biologics as well as small molecule drugs (Heilborn et al, 2021).
With the emergence of Artificial Intelligence (AI) in this century, protein library design is better informed and improved (Xu et al, 2021). It is a more efficient and sustainable scale-up option for drug manufacture. Next-generation sequencing has dramatically increased the inventory of available genetic pieces, which we can accurately synthesize and incorporate into libraries, chassis organisms, and biocatalysts to serve these purposes.
Synthetic biology has had an impact on traditional small molecule medication development vs biologics. Synthetic biologics are increasingly being created from optimized, error-free DNA building blocks. Synbio, which enabled synthetic insulin in the 1980s, is currently changing antibody discovery and T-cell therapy research (Webed, Wilfried & Fussenegger, 2019).The tiny gene encoding insulin, for example, takes months to synthesise, but libraries containing tens of billions of antibody genes may now be synthesised in a matter of weeks. Instead of randomly produced sequences, the library now only comprises sequences that exist in the human repertory. Screening technology is also improving, with single B-cell sequencing and viral display enabling for quick assessment of medication candidates. (Webed, Wilfried & Fussenegger, 2019).
The deep revolution in pharma these days is all about the drug development pipeline management. Previously, firms concentrated their research efforts primarily in-house, bearing the cost of developing the infrastructure to identify new candidate biologics. Outsourcing to partner organizations with expertise in a certain step of the discovery pipeline is becoming more popular as development times and costs can be reduced dramatically. Companies are also going 'lab-free,' outsourcing the entire procedure (Forum on Neuroscience and Nervous System Disorders et al, 2014).
But?
There is always a but in these advanced AI which in this case speed would be a challenge and how can we make drug discovery to be faster while improving throughput?
Part of this is due to the fact that some technologies have evolved more quickly than others. For decades, DNA synthesis methods have been lagging behind DNA sequencing technology.
Synthetic biology, which exists at the intersection of biology and engineering, is poised to become one of the leading medical technologies of the twenty-first century. Working in this subject at the moment is a thrilling experience. However, the potential of synthetic biology extends far beyond improving human health, as its use could assist researchers in addressing some of the world's most serious environmental and sustainability concerns.
Article prepared by: Nur Anis Afifah Mohd Elias, Research and Development Associate of MBIOS 23/24
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References
Yan, X., Liu, X., Zhao, C. et al. Applications of synthetic biology in medical and pharmaceutical fields. Sig Transduct Target Ther 8, 199 (2023). https://doi.org/10.1038/s41392-023-01440-5
Bell, E.L., Finnigan, W., France, S.P. et al. Biocatalysis. Nat Rev Methods Primers 1, 46 (2021). https://doi.org/10.1038/s43586-021-00044-z
Heilbron, K. et al. (2021) ‘Advancing drug discovery using the power of the human genome’, The Journal of Pathology, 254(4), pp. 418–429. doi:10.1002/path.5664.
Xu, Yongjun, et al. “Artificial Intelligence: A Powerful Paradigm for Scientific Research.” The Innovation, vol. 2, no. 4, 2021, p. 100179. Sciencedirect, www.sciencedirect.com/science/article/pii/S2666675821001041, https://doi.org/10.1016/j.xinn.2021.100179.
Weber, Wilfried, and Martin Fussenegger. “The Impact of Synthetic Biology on Drug Discovery.” Drug Discovery Today, vol. 14, no. 19-20, Oct. 2009, pp. 956–963, https://doi.org/10.1016/j.drudis.2009.06.010. Accessed 8 Feb. 2019.
Forum on Neuroscience and Nervous System Disorders, et al. “Drug Development Challenges.” Nih.gov, National Academies Press (US), 6 Feb. 2014, www.ncbi.nlm.nih.gov/books/NBK195047/.