Week 1 - Assignment
Since the industrial era, human activity has profoundly transformed the Earth, our impact range from the macroscopic to the microscopic, with one of the most striking examples being plastic pollution. Since its invention, an estimated 8.3 billion tons of plastic have been produced, with approximately 70% accumulating in the environment.
Plastics have become so pervasive that recent studies have detected microplastics even within the human body. A major concern is their persistence as these non-reactive materials cannot be effectively targeted by the immune system, potentially leading to accumulation, blockages, and tissue damage. Countermeasures must be designed to tackle this problem, a possible development idea would be the genetic engineering of human macrophages to effectively recognize plastic materials and degrade them by making them express specific plastic-degrading enzymes such as PETases or MHETases which have been found effectively produced in bacteria.
In the design of synthetic therapeutical practices risk evaluation is one of the main steps as the safety of the patient is the highest priority. For this reason, it is mandatory to conduct preclinical and clinical testing to assess potential immunogenicity, toxicity, and unintended interactions with the human host. Moreover, since the technology could alter the delicate equilibrium of the host, genetic tools should be implemented to prevent overactivation or uncontrolled proliferation of engineered macrophages.
The body environment is complex and many therapies experience off-target effects. Macrophages have to be designed with highly specific receptors to recognize and degrade only plastic materials, preventing interference with natural biological structures. In doing so, developing long-term monitoring protocols for macrophages activity is essential to study long-term effects on human health.
Finally, containment solutions mus be adopted to avoid environmental leakage if modified macrophages are inadvertently released or persist beyond intended use.
Purpose
This projects present many challenges as current cell-based treatments are not designed for long term functioning under a prolonged environmental exposure (the continuative ingestion of microplastics), meaning that an appropriate rule framework for approval is nowadays missing. This calls for a specialized regulatory approval pathway to ensure safety, efficacy, and long-term monitoring before human trials and clinical use.
Design
The interplay of many organs is required to ensure a correct research and market entry for the therapy, starting from synthetic biology researchers and biotech companies to ultimately being approved by official regulators (WHO, FDA, EMA, etc…).
It is essential to monitor the long term effects through mandatory patient follow-ups and federal organisation should make companies apply post-market surveillance actions.