We have presented here the pathologies illustrating the most the mortality due to the lack of access to healthcare. However, we can imagine that our box can also respond to certain chronic conditions. Besides, we should not forget that our box is not a frozen project. Around its role of automated production and purification, it leaves a large room for its optimization and allows us to work on a decreased production time and an increased quantity of proteins production. The possible optimization of the box could also revolve in the creation of a more or less storage, an ephemeral method to compensate for the time variable of production. It should be noted that this box is also a solution to the ethical problems related to obtaining of some serum proteins from animal immunization or for the production of hormones. In this way, it would be a solution to the problem of immunogenicity of these serotherapies in humans.
In fact, this could be an alternative to the animal use for the production of drugs in general.
As described in the state of art we talked to MSF and the start up MedTrucks to know more about the qualitative and quantitative data from the field. Then, our discussions went forward to thinking on a possible partnership with each of them in the futur. More precisely, our discussion with MedTrucks first focused on the
abilities of their trucks to insert our box. The size of some of their trucks allows our partnership. In fact, we all think that working in partnership could change the face of the actual access to healthcare through the assembly of our box and their travels in places and knowledge of the work in the ground. We are also currently working on a potential partnership with a woman working on the creation of a clinic in a isolated region of Cameroon.
In conclusion, Our Biomaker Factory aims to completely disrupt today's global healthcare system. Indeed, thanks to our machine and with the cooperation of other structures such as MedTrucks, the production will be relocated to the place where medicines are needed with lower cost and no problem due to conservation. Moreover, the production will directly meet the demand; thus, there will be no intermediaries and no overproduction: this will allow to make medicine with a low price, as close to the cost of production as possible.
Limit on a short term: Legal Issues
As a part of our Human Practices collaboration, we asked the Jurist of the Evry/Paris-Saclay team, Maxime de la Fouchardière, to help us about the legal issues that could come with the production if recombinant proteins in France and in general in the EU.
Our first question was about the production of recombinant proteins for the research purposes, would it create any issues. Maxime told us that research in France and moreover in Europe knows actually very few regulations regarding the act in itself or its subject. This freedom is guaranteed by the French Code of Research. Besides this legal freedom, there are strong regulations regarding biomedical studies if they are conduct on animals or on human beings. Nevertheless, if GMO in research are authorized, their use and their deliberate release is strictly set by the French Environment Code. It means for us, that we can use and produce recombinant proteins as long as the GMO we use to produce them are safely kept.
But let’s not forget that our project is to produce recombinant proteins for a human therapeutic use. Maxime then explained us that in France the drug market is tightly controlled by the French Agency for Drugs Safety, the ANSM. According to the French Public Health Code, is considered as a drug any substance that is said to have any curative or preventive properties. To be authorized, a drug candidate must go through the Drug Marketing Authorization process or AMM in France. This a difficult procedure in which the drug needs to fulfil precise criteria: it must have a favorable risk-benefits balance, have a therapeutic effect and have the same composition as the one registered in the application form. It must go to through several test phases on animals and humans where lot of data will be gathered to provide the right information on the well-use of the drug.
This whole process can take up to 10 years and costs billions of euros. However, it exists few cases in which a drug can be sold with no AMM:
The Temporary Authorization of Use (ATU):
If a drug doesn’t have any AMM and has significant positive result in the clinical trials, doctors can be authorized to prescribe the drug. But this is only possible if the disease concerned is sufficiently rare or severe.
The Temporary Recommendation of Use (RTU):
Grant the possibility for a doctor to prescribe a drug if there is no other possibility of treatments, with conditions ruled by the ANSM
Doing further analysis on how our box and the proteins it produces could be used in the market we thought that the we could produce proteins or hormones used in the livestock industry.
Maxime has then given us insight on how such molecules could be authorized: In France, and on the European scale, the companies that want to sell a new molecule on the European market, must get their products assess buy the European Food Safety Agency (ENSA). They will go through a process where they must produce a study of the risk of their molecule. the result will be analyzed by the ENSA, which will allow the molecule if it doesn’t present any harmful effect for the human and animal health and also if it doesn’t show any unacceptable risk for the environment. If allowed the molecule will be registered in the list of authorized molecules. To be then authorized in France the molecule will be analyzed by the French regulating agency for food and sanitary security (ANSES). The ANSES will verify if the molecule registered has the right composition and basically do a similar work as the ENSA.
This whole process is much shorter than the AMM and can take up to 3 to 5 years.
Going forward with this new mode of production
We can easily imagine many other uses for our box. The necessary production of these proteins must therefore be consistent with the capacity of the box in terms of time and quantity of production. Thus, we can offer a specific production between manual work at the benchtop and companies large-scale bioproduction. This would be a major gain of time and money relative to the optimization of a specific strain research and to the production of the protein by a research laboratory engineer. In addition, this box is an invitation to the development of synthetic biology in the countries it will be used in. We can hope for an independent development of these countries through diverse and varied opportunities
would be the source of potential local partners and therefore enable the specific development of our own strain library according to the local needs and regulations for instance.