CRISPR and the Rebirth of Synthetic Biology

Abstract

Emergence of novel genome engineering technologies such as clustered regularly interspaced short palindromic repeat (CRISPR) has refocused attention on unresolved ethical complications of synthetic biology. Biosecurity concerns, deontological issues and human right aspects of genome editing have been the subject of in-depth debate; however, a lack of transparent regulatory guidelines, outdated governance codes, inefficient time-consuming clinical trial pathways and frequent misunderstanding of the scientific potential of cutting-edge technologies have created substantial obstacles to translational research in this area. While a precautionary principle should be applied at all stages of genome engineering research, the stigma of germline editing, synthesis of new life forms and unrealistic presentation of current technologies should not arrest the transition of new therapeutic, diagnostic or preventive tools from research to clinic. We provide a brief review on the present regulation of CRISPR and discuss the translational aspect of genome engineering research and patient autonomy with respect to the "right to try" potential novel non-germline gene therapies.

The Consent Form in the Chinese CRISPR Study: In Search of Ethical Gene Editing

“…Quite apart from the concerns about premature risk of germ-line CRISPR modification, the participants in this study were clearly misinformed about the study's purpose, as well as being subjected to considerable pressure (via free IVF) to take part. Germ-line editing of human embryos intended for implantation is already ethically fraught (Heidari et al 2017) without introducing further ethical issues in the consent materials. Ethical gene editing requires ethical consent and information materials, and ethical principles require at least a degree of ethical content.…”

Advances in Synthetic Biology and Biosafety Governance

“…With the application of novel gene editing technologies such as CRISPR/Cas, engineered S. cerevisiae could be used to produce a variety of chemicals. A representative success case is the manufacturing of artemisinin precursor, artemisinin acid (Ro et al, 2006;Heidari et al, 2017). Moreover, researchers have been able to fully synthesize opioids in yeast (Galanie et al, 2016).…”

Rising influence of synthetic biology in regenerative medicine

“…With its use, researchers can introduce correct mutations into the genomes of cells and organisms with a level of ease and proficiency that was not previously possible [90]. It is because of this that CRISPR-Cas9 offers unparalleled opportunities in fighting genetic disease, the targeted modification of whole genomes, in vivo models for drug discovery [88] as well in cell therapy and regenerative medicine [90,91]. Given the rapid pace of the fields development, the technology is continuously adapting and improving.…”

“…Heidari et al [91] state that these limitations are brought on by our limited understanding of genetics. As such, if technologies such as CRISPR are to reach their full potential and be translated to the clinic, we must first gain a better understanding of genetic disorders, particularly those involving multiple genes and the genetic interventions required, and then find methods to surpass the pre-existing translational barriers surrounding gene therapies.…”

“…Despite this, although CRISPR‐Cas9 is considered the gold standard technology, especially when compared to other genome‐editing technologies [92, 93], it too experiences some limitations with regards to greater understanding of off‐target effects and optimisation in application that must be dealt with before being viable for altering the human germline for preventive purposes. Heidari et al [91] state that these limitations are brought on by our limited understanding of genetics. As such, if technologies such as CRISPR are to reach their full potential and be translated to the clinic, we must first gain a better understanding of genetic disorders, particularly those involving multiple genes and the genetic interventions required, and then find methods to surpass the pre‐existing translational barriers surrounding gene therapies.…”