During the development of our project we worked on two different Laboratories, one being the Microbiotechnology Laboratory located at the University of Guanajuato Campus Irapuato Salamanca and the other one at the National Polytechnic Institute UPIIG (IPN- UPIGG) Each of our project components which are detailed through our wiki as two main sections: Molecular Lab and Patch Lab were performed under the standard Biosafety procedures of each laboratory and designed under the feedback of our talk with experts on the field and on our Study on the Regulatory Framework that governs the creation of Biotechnological products in our country.
Molecular Lab & Patch Lab
Before entering the Lab Proper Laboratory training was given to the students in order to comply to the Laboratory Guidelines. Training from the Microbiotechnology Lab and the IPN-UPIIG lab was carried out by the principal Investigator Dr. Eleazar Barboza and by Dr.Karla Macias , respectively.
Since we are working with bacteria of the Risk groups 1 and 2, we carried out, all our experiments in a laminar flow hood. In the biosafety cabinet, we use the proper protection such as gloves and used sterilize loops in order to prevent any contamination both, to us and to our work. All the waste materials used to handle and growth bacteria were properly sterilized. We frequently clean with alcohol our open bench. Also, as when we are working with different procedures to extract or amplify bacterial DNA, we used gloves and lab coat to handle them.
Our project utilized as chassis two non-pathogenic bacteria such as E. coli K12 and Lactococcus lactis. And although they are not considered as pathogens in the intestine, we do not know whether they have any negative effect in the skin, considering the possibility that bacteria could be release from the patch. In this regard, proper experiments in order to avoid the release of the bacteria were done in order to check the permeability of the material used for our patch.
However in order to comply with the mandatory risk assessment studies and Biocompatibility studies that are required from the Secretary of Health of Mexico, additional future experiments to discard a negative effect in the skin owing to E. coli K12 and L. lactis must be carry out.
Regulatory Framework of Biotechnological Products in Mexico
During the development of our project we decided to go a bit further and learn more about the legislation required in our country for the creation of this type of technology in case this project ever goes out of the Lab. This was a very important part of the project we wanted to study before the final design of our product was done because in order for it to be successful, it must first comply with all the Biosecurity and Biosafety standards that the Law demands. In order to do this we decided to work alongside law students from the University of Guanajuato to see how Mexico is doing in terms of the regulation of products derived from biotechnology and synthetic biology and too see what parts of our project are required in order for them to be innocuous to humans.