Synopsis

Our scientific ability to understand, build and apply the programming language of life – the genetic code - is increasing at a rapid pace. In modern biotechnology and including the emerging field of 'synthetic biology' several scientific disciplines specifically aim to apply and make use of this genetic programming language in a way that is beneficial for man and society. Synthetic biology has a broad range of possible fields of application, one of which is medical products. Here we report on a quick scan to identify medical products which are currently being developed using synthetic biology. Additionally, we identified the applicable regulatory frameworks.

On the basis of our investigation we identified three groups of medical products: biosensors, targeted drug delivery products and engineered human cell products. The results confirm that the evolving field of synthetic biology indeed holds promise with regard to medical applications. It will, however, probably take time before most of the products will actually reach broad application in the clinic. Two types of regulatory frameworks are applicable: to cover the use of genetically modified organisms and to regulate medical products. New medical products obtained using synthetic biology might challenge the existing regulatory frameworks and this quick scan can serve as a basis to identify such challenges in cooperation with key opinion leaders in the field.