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In three years, they hope to be manufacturing it in their new plant to begin trials.
We hope that the pandemic will be over before we have our vaccines," says Carlos Genzor, founding partner and technical director of Certest Biotec. Because the project they presented last Thursday is "long-term." It takes its first steps with the objective to develop a system to develop messenger RNA (mRNA) vaccines. With an investment of 100 million euros, the challenge is that "in three years we will have a prototype and industrial manufacturing capacity" in the new plant they have built. projected.
A group of ten researchers is already working on the project. They will begin by focusing their efforts on the coronavirus, but the mRNA strategy "opens up a new panorama, a new way of making vaccines - against the coronavirus and against other viruses and bacteria - faster, more efficient, simpler," highlights Genzor. .
It is the technology of the Pfizer and Moderna vaccines, which have shown that inoculating messenger RNA, with the instructions for our own cells to make the protein with which SARS CoV-2 infects, works. It trains our immune system, which recognizes it as foreign and makes antibodies and T lymphocytes against it.
At Certest "we do not have experience in vaccines, we are a diagnostic manufacturer – Genzor acknowledges – however, we master key technologies: we make enzymes, we work with nucleic acid sequences, we synthesize them...". They also have "experience in handling RNA." In fact, the diagnostic tests they manufacture now are on RNA, not on the messenger, but on the RNA of the virus.
The RNA molecule is delicate. That is why the research conditions, and especially those for the manufacturing of mRNA vaccines, are very demanding, in completely sterile facilities, in a clean room environment. This fragility means that intense work is required to give stability to the RNA sequence itself and also to encapsulate it in lipid nanoparticles that protect it as much as possible. "Optimizing this is the most complicated and we think it is where we can contribute something" that makes them differentiate themselves.
Without freezing
And while the Pfizer and Moderna vaccines require ultra-freezing, Certest aspires to achieve a messenger RNA vaccine prototype that is stable at room temperature. Precisely the reagents of their PCR tests "are kept at room temperature for two years, while others require cold. We can also provide that technology that we have in the tests." For this reason, they hope not to have to build superfreezers attached to the 12.000 m2 built plant that they already have drawn on paper.
But, for now, he warns, "until we have the RNA prototype we will not be able to encapsulate it or test its stability over time. It is a project in its infancy, which we are defining." Furthermore, if all goes well, in three years, a vaccine candidate tested in vitro and in animals would emerge from Certest Biotec and, from there, it would be necessary to "seek an agreement or cooperation with companies or entities that could collaborate in the costly clinical trial phases in humans". The doses for the volunteers in these trials would already be produced in their new plant. And in the future, when faced with the next emerging disease, "our idea is to be prepared to react quickly when we have a similar problem."
