Read the Conversation
EF: If health had its own COP26 and you were a speaker, what would be your message to world leaders?
AR: As a Latin American regional player, I believe the most important thing for our region is preparedness. To be prepared means being self-sufficient when regarding health. We cannot rely on other countries shipping products to Mexico, and this change will not happen from one day to another. Being prepared requires a lot of planning; pharmaceutical companies must invest in R&D and technology, keep up with all the advancements in technology, and achieve collaboration between the public and private sectors. Private enterprises must continue to invest in infrastructure, R&D, and new technologies, whereas the public sector should acknowledge the importance of developing local industry. We need a robust regulatory agency with international standards because the created technologies have to comply with the regulatory agency standards throughout the world. Regulatory agencies should be harmonized, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) already exists, and we need to go a step further and harmonize in practical terms, not just theoretically. Regional collaborations are also a must; I am very proud of our technology transfer and manufacturing of the AstraZeneca vaccine –the most used vaccine in Mexico. It's a clear example of international collaboration; Oxford University, one of the most reputable institutions globally, created the vaccine and collaborated to manufacture and distribute the vaccine. The University stipulated that it be a non-profit project while the pandemic lasted. I feel honoured to be part of this collaboration; it brought out the best in all participants and technology transfer to the world. We worked daily with AstraZeneca and mAbxience in Argentina for the collaboration to succeed. Technology has brought us all together; we have collaborated with partners worldwide, and this model could be used to develop other products significant to our region. It could be used to fight neglected diseases in our parts of the world, such as dengue, Zika, Chikungunya, and Chagas disease. To summarize, self-sufficiency, innovative technology, and collaboration from the government to bring local and regional companies together to develop biosimilars, monoclonal antibodies, recombinant vaccines, and other products to address neglected diseases in the region.
When prepared, opportunities will appear. The collaboration between multinationals and local players is an opportunity to manufacture and produce. In 2019 we inaugurated a new production site specifically designed for the manufacture of recombinant vaccines, we had initially planned the site for an influenza vaccine, but the environment changed. We had a facility with state-of-the-art technology based on isomers, the highest level of sterile production technology. It was the first production site of this technology in Latin America, so when the pandemic started, Dr. Roberto Tapia of the Slim Foundation explored the possibilities of making the drug substance and the fill and finish product in the region. We had considered doing the drug substance as we had inaugurated a facility for cell culture at the end of 2019, but as it is a small site, the decision was taken for mAbxience in Argentina to manufacture the drug substance and for Liomont to do the fill and finish using our site. We were under pressure to have the facility ready with adequate technology as specific processes differed from what we had. We purchased the equipment and put everything together as fast as we could. Technology transfers of this kind in the industry take at least a year and a half and up to two or three years, but I am very proud to say we managed it in seven months from the beginning till when we started manufacturing. We brought in 300 people to the project, trained them, and they are now capable of producing at a very high level of production. We currently produce twenty million doses per month, something I consider quite an achievement.
EF: What were the lessons learned managing during this process and the pandemic?
AR: Preparedness was vital. We learned a lot through this experience which I consider the biggest technological challenge of my career; we now know we can produce any vaccine we can get our hands on. We have worked for years with academic institutions in Mexico, particularly with the department of biology of the UNAM, developing monoclonal antibodies that we are licensing out to the world. The vaccine has been produced with the most stringent international standards making us competitive in regional and international markets. Latin America is seen as the world laggard in manufacturing high technology products, but I beg to differ. After our collaboration with AstraZeneca and Argentina, I am convinced that our region has the capacity and the talent to be competitive anywhere in the world.
EF: Could you elaborate on the collaboration itself and how it came around?
AR: When AstraZeneca announced the first known vaccine, as a response to Covid, Dr. Roberto Tapia, whom I have known for many years, contacted us to say he was exploring the possibility of local companies manufacturing the vaccine. We had conversations with AstraZeneca; mAbxience included us in the project, and things progressed. I have a close relationship with Dr. Sigman, who headed the project from Argentina, and everything came together. We signed an agreement in late August 2020 and lost no time in pushing the site into the required conditions, cold chambers, ultra freezers, and other required equipment. The government facilitated many imports and was an essential and crucial part of the equation; we had weekly meetings with Foreign Affairs and COFEPRIS. Under pressure, we all worked together in a collaborative environment to fulfil our purpose. Working together to make things happen was the most rewarding and fantastic experience of my career, and without doubt, the most challenging one I have ever experienced. The collaboration of all the actors for a purpose was indeed a lesson learned.
One of the challenges we had was around acquiring all the components needed to manufacture the vaccine. With single-use technology (a state-of-the-art production technology for sterile products), the filters, single-use bags, and other components are manufactured by very few manufacturers worldwide. We had some problems with executive orders as the manufacturers of the filters, and single-use technology products gave priority to United States-based companies. We needed the support of the Secretary of Foreign Affairs to intervene directly with some of these companies to get priority. The companies were not prepared to grow their production five times from one day to another, and due to the lack of filters and single-use bags technology, our production was slightly delayed. From day one, we had to have stock for the whole production, and we had to buy stock for 15 million vials that allowed for 150 million doses. We could not buy them gradually because if we had to order new vials, they would have a delivery timeline of eighteen months. Fortunately, we were able to solve that situation with the government's help and the collaboration with mAbxience; they were out of single-use bags, and we were out of filters, so we interchanged the extra materials, and we didn't have to stop production. An important question to answer is: how does the state of the art installed capacity can help shape an industrial policy that will sustainably foster innovation and self-sufficiency?
We have shown that we are capable of partnering, responding and delivering in front of a health emergency, but it is crucial that the installed capacity and state of the art infrastructure remains productive in the long term.
EF: On the one hand, you were producing vaccines, but you also have a portfolio; how did you balance both, how did the product portfolio evolve?
AR: Our portfolio evolved a lot throughout these past times. Some products were barely sold, for example, pediatric products. Because children stayed at home for a year, they didn't get any of the usual contagious diseases, which impacted the market and our portfolio. The demand for flu and respiratory products collapsed due to constant mask-wearing, but on the other hand, our chronic disease products such as diabetes and cardiometabolic products grew, mainly because people wanted to be protected and looked after themselves more responsibly. Some antibiotic products also had growth as doctors were trying out different therapies. The market changed a lot in 2020, but this year it has stabilized, especially since children have gone back to school and people started going out, things have gradually gone back to what they were. We focused on vaccine production and looking after our collaborators in our traditional business. Our sales force has changed, after keeping them indoors for a year. Our working habits changed drastically, as in many other companies, to working from home and it worked out very well for us. One of the main lessons learned throughout the world is that we can work very successfully in the new remote mode. We were concerned about the safety and wellbeing of our people, and because we are technologically inclined, we immediately developed an in-house PCR test. From May 2020, we had our PCR tests and started establishing confinements for different groups, which helped a lot. We have a statistic that shows 30% of all our staff has had Covid, which might sound like a lot, but it is high only because we were testing so much. If we tested at that level in all the population, this is the figure we would have at a country level.
EF: Do you think the new way of collaboration will set a precedent for the future?
AR: Collaboration will set a precedent for the future, we already have different kinds of contracts signed for developing monoclonal antibodies, and this is an excellent example of the collaboration that can be achieved for other products, both for in-licensing and out-licensing. We are expanding the experience to licensing projects, both in and out. We are developing technologies to have the capacity to go ahead with in-licensing and out-licensing.
EF: Did you ever think you would be in such a key role, managing through a pandemic?
AR: In 2009, we were important players during the influenza pandemic, much smaller than Covid, and at the time, we manufactured the product for the Mexican government. Nobody foresaw Covid or the scale of the pandemic, but we are always willing to cooperate in finding solutions in health situations or crises. We believe our mission is to alleviate human pain and save lives. We are delighted to know we have spared human lives -we know for a fact that vaccines save lives. I never thought I would be such a relevant part of the solution.
EF: When you wrap up this year, what will your message be to your collaborators?
AR: I will be thanking my team for working endlessly and with incredible commitment. I am so thankful to the Liomont team that made it all happen. Satisfaction in terms of achievements has shown what we can do; being prepared has made us stronger for the future. The team made it happen, and I am exceedingly proud of what we have done. Having participated in saving lives is extraordinary. Depending on the variants, we are prepared and ready to continue producing vaccines or do whatever is needed for a seasonal vaccine. Questions have yet to be answered, but we can collaborate with whatever is required. We also want to be considered along with other international players for future challenges, and we are very open to new relationships with different players.
