The goal of our BioBricks will be to produce full-length immunoglobulin molecules using the E. coli strain Shuffle. Our team will only be designing the plasmids containing our desired sequences and will not be using any whole organisms nor chassis organisms in our project. We hope that by designing these plasmids, we can create an inexpensive method of antibody production for use in immunoassay and immunotherapy options.
Our team will be using our laboratory space for biochemical experiments regarding the setup of our lateral flow assay. These experiments will include the assembly of a test strip using cellulose and glass fiber-based membranes. Several antibodies will be deposited onto the test strip, including an antibody labeled with gold nanoparticles. Additionally, we will be testing the efficacy of the UV sterilizer using a non-pathogenic strain of E. coli. All experiments will follow established protocols in alignment with the biosafety hazard level of our laboratory space (BSL-2) and the rules put forth by the department of environmental health and safety (EH&S) on campus. Therefore, there is minimal risk associated with the experiments that we perform in the laboratory space. All chemical work will be done under a fume hood and waste will be deposited off in the proper biohazard containers.
Our hardware team will be designing all devices (centrifuge and UV sterilizer) prior to physical construction to ensure that all designs will function safely and correctly. Hardware has received an approved safety form on behalf of EH&S that outlines further restrictions upon which chemicals may be used, which voltages are permitted, and when a circuit or device may be turned on. All work done by the hardware team will be supervised by the most experienced member of the team to minimize risk.
All members of the team have received proper safety training on the following topics as determined by EH&S: laboratory access and rules, responsible individuals, differences between biosafety levels, biosafety equipment, good microbial technique, emergency procedures, physical biosecurity, personnel biosecurity, chemicals, fire, and electrical safety. We also have other risk management tools to cover our work including accident reporting, personal protective equipment (PPE), inventory control system, access controls, waste management system, medical surveillance, and special procedures or protocols that address safety or security. Our PI is responsible for overseeing the laboratory space and ensuring our team’s compliance with the safety protocols and procedures set forth by the university.
For the implementation of our design into a real product, we recommend that people use our lateral flow assay test strips in a small enclosed device in a laboratory or clinical setting. The implementation of our design would require proper biohazard safety steps in regards to the collection and handling of the biological sample (menstrual effluent) for the assay. Minimal laboratory steps would be required to prepare the samples for testing with limited centrifugation and serum separation steps. The risk of using a biological sample includes accidental exposure to bloodborne pathogens, which can be minimized by using proper protective equipment when handling the sample. We also recommend that a medical or laboratory professional runs our assay in a clinical or laboratory setting with proper safety protocols in place. Once the serum has been separated, the sample can then be used in the lateral flow assay to identify key biomarkers of endometriosis and provide a diagnosis.
Safety Proposal for Off Campus Use
The hardware team presented a safety proposal to the Environmental Health & Safety - University of Rochester. The proposal was presented in hopes of getting approval on the use of electronic components and pieces outside the University's laboratories.
The safety proposal included presenting the general design of the project, the materials and tools required to use, our expected assembly technique- to emphasize our methods of opting out of using power tools and soldering and relying on simply hand tools. The team also submitted the additional safety procedures and precautions especially considering maximum voltage use.
We also mentioned additional precautions and measures that were taken concerning circuit building, power control, alternative voltages and avoiding the use of any biological and biomedical substances. Additional precautions included the explanation of the individual's COVID-19 work space
Finally, we tackled all the team members' experiences with circuit building, Arduino use, wire crimping and hand tool use.