Building Sustainable Biosafety & Biosecurity for Synthetic Biopharmaceuticals

International prevention and control of infectious diseases requires a robust diseases surveillance and diagnostics platform. The major biopharmaceutical concern, particularly with microbial systems, is that genetically modified self-replicating cells may produce gene products with unknown consequences if there is a loss of containment to the environment. To address this biosafety concern, many strategies considered to address the mechanisms for constraining microbial cell replication and horizontal gene transfer. Recombinant containment strategies are considered to built into vector systems like preventing the spread of recombinant and synthetic DNA to host organisms either through horizontal gene transfer (HGT) or avoiding loss of containment of the engineered organism releases to environment. However, synthetic biology biosafety also depends on the genetic cargo of the vector and the protein with an unknown pharmacological or environmental effect. The explosions of interests in biosafety and biosecurity in recent times with steady increase in facilities and labs handling pathogens, nanoparticles, markers, toxins, biomaterials for 3D printing in translational research, cell therapy and personalized medicines have made biosafety-biosecurity awareness and knowledge is more important than ever. Biosafety is about applying right knowledge, techniques and equipment’s to prevent exposures to potentially infectious materials or biohazards. Biosecurity is the process employed for ensuring biological agents are properly secured and protected against theft, or unauthorized access or use/release. One of the most important decisions to be made in working with biohazardous agents is the selection or development of work practices to prevent exposures. An agent- and protocol-based risk assessment should provide sufficient information to allow for the selection of the appropriate level of containment for the work. Importantly, security in biology differs from that in a nuclear or chemical enterprise—biological materials are ubiquitous in nature and due its covert nature could induce an epidemic with less time to react and contain the exposure.