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Since 2015, before the coronavirus pandemic monopolized scientific research, biotech engineer Pavel Marichal Gallardo from Tec de Monterrey, had been working with viral particles to develop vaccines.

In an interview with Tec Review, Marichal Gallardo says that what began in his doctorate classes is now ContiVir, a company on the way to creating a vaccine that can combat SARS-CoV-2.

Five years ago, Marichal was pursuing his doctorate in bioprocess engineering at the Max Planck Institute for Dynamics of Complex Technical Systems, in Magdeburg, Germany.

The biotechnologist began his specialization working on viral vectors, used in gene therapy, with a modified version of the virus that causes the eradicated smallpox, as well as the adeno-associated virus, which infects humans and some primates.

Gene therapy consists of treating diseases by altering a patient’s genetic code. That is to say that “a healthy copy of a defective gene is inserted into the patient’s cells” according to the National Human Genome Research Institute in the United States.

This Mexican says that his shifts in the laboratory have now doubled to ensure progress on the creation of a vaccine that will help end the lockdown.

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How did you start your company Contivir?

During the final stretch of my doctorate I got to know a colleague from Chile, Felipe Tapia, who worked in the same research group, but on cell culture.

We decided to combine the technologies we had developed (for which we had applied for patents) to start a company with the goal of revolutionizing the production of viral vaccines and gene therapies.

We received 1.1 million Euros for a two-year project, starting in October 2019, in order to commercialize these technologies and in the end create a company. For the business development aspect, we were joined by Julián López Meza, another alumnus from Tec de Monterrey.

What progress is ContiVir making towards a Covid-19 vaccine?

Our project focuses more on the technological systems that will allow us to produce gene therapies and vaccines, like that for Covid-19.

We are currently testing our systems with various viruses, including a particle based on the coronavirus.

We estimate to be producing a candidate by the end of July, as we are waiting for some materials that we don’t manufacture ourselves.

Alternatively, we have a contact who can test our purification system with their own candidate vaccine which was listed with the World Health Organization (WHO).

How can you massively scale up the production of your vaccine, once it is approved?

At the moment we have laboratory prototypes that can produce up to 20 times more than current technologies. We hope that in around 12 months from now we will have equipment for both pilot and industrial plant production.

An important thing to note is that our technologies allow the adaptation of spaces that would not have been considered for the production of viral particles before.

For example, a laboratory with a five-liter bioreactor adapted to our technologies can produce up to 100 liters per month, a quantity of product used in a pilot plant: an intermediate level between laboratory production and industrial production.

Are you in contact with research centers in Mexico to support efforts for containing Covid-19 through the use of vaccines?

I last had the pleasure of seeing Laura Palomares at a conference in Canada in 2018. I wrote to her a few weeks ago about collaborating with her Covid-19 candidate vaccine and we agreed that we would discuss how we could collaborate in the future. I hope to talk to her about it soon.

I’m also in contact with researchers and former colleagues at the Tec’s Monterrey campus.

How safe is gene therapy?

Gene therapy is the replacement of a defective gene in a patient in order to restore normal tissue or organ function. Gene therapy could be the next medical revolution as it has the potential to treat many diseases for which there are no cures or treatments.

There have already been many important clinical successes with approved products on the market, e.g. for one type of blindness or for muscular dystrophies that are lethal to patients.

The gene can be introduced into the patient’s body in several ways, but the most common is through a virus that has been modified to be harmless and to contain therapeutic genetic material. These are called viral vectors.

Viral vectors can also be used for vaccination. They can be modified to express or produce an antigen that will generate an immune response in a patient for this purpose. For example, an adenovirus (Ad) or adeno-associated virus (AAV) expresses a protein from the problem virus, so that the organism recognizes it and generates defenses against future infection.

Is it slower to develop than recombinant vaccines? What are its advantages against other vaccines?

Viruses typically generate stronger immune responses than individual recombinant proteins, meaning that less product is needed for a similar level of response.

It takes 10 to 15 years for any biopharmaceutical to reach the market. However, with many diseases for which there is no current treatment or cure, they can be approved by a country’s health authorities more rapidly than that to be made available to the population.

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What is the main challenge in working with gene therapy vaccines?

With any therapy that requires viruses (vaccines or gene therapies) there is currently a serious problem: the existing methods for their production and purification are very inefficient and difficult to scale.

For example, only a few hundred treatments can be produced per year for some genetic muscle diseases, because of the huge amount of viral particles required.

The demand for viral particles is currently estimated to exceed supply by a factor of five. This situation will only worsen as demand increases and new therapies are approved more quickly in the future.

What other challenges does the development of gene therapy vaccines face?

The manufacture of viral particles in the biopharmaceutical industry continues to be done in batches, unlike the petrochemical industry, for example, whose production is continuous and therefore much more efficient.

In addition to being produced in batches, today’s methods require a lot of manual labor, are extremely slow, and use processes specific to each different product. For different therapies, the processes have to be adapted significantly. Finally, many existing technologies are not scalable to an industrial level and are only suitable for small laboratories.

This is where ContiVir technology comes in. Our technologies are at least ten times more efficient than existing technologies, which will allow the mass production of viral vaccines and gene therapies in a shorter period of time.

Will you prioritize distribution in Germany, or where will the first markets that ContiVir reaches be?

At the moment we are in the testing phase of our technologies with potential customers, and any organization on the planet that has a Covid-19 candidate vaccine based on a viral particle can use our products (blue areas in the image).

We are currently in discussions with several large companies about the possibility of using our technologies, and are working with various research groups that have candidates for gene therapy and Covid-19 vaccines. Simply because of geography, the majority of our contacts at the moment are in Germany and Switzerland

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