Technology transfer and tender won: Sinergium biotech creates a strong alliance with the company Sinovac in order to complete a new technology transfer for the production of the hepatitis A vaccine.
The successful introduction of a vaccine into an immunization program is a significant achievement for any country, with vaccines being a fundamental tool in disease prevention. Its availability and adequate coverage can have a positive impact on the health of the population. Argentina has demonstrated notable success in implementing a vaccination scheme against Hepatitis A, being a model in the region of the Americas, which has contributed to the reduction of cases of this disease and the protection of the health of its citizens.
In this context, Sinergium Biotech, as a pharmaceutical company, plays an essential role in the production and distribution of vaccines in our country. Through the replication of successful cases of technology transfer, our company has partnered with Sinovac to complete a technological transfer for the production of the Hepatitis A vaccine. During the year 2023, our company has taken the first step to finalize this alliance by participating in the public tender for the supply of 710,000 doses of vaccines for adults and children. Recently, our offer has been the only one valid for the award because it has the lowest price and complies with all the conditions required by the specifications. With our VAXIPAT vaccine, we have the opportunity to significantly contribute to improving vaccination coverage next year at a price lower than what Argentina would have accessed through the Revolving Fund of the Pan American Health Organization, competing with the largest multinational laboratories.
This implies that more Argentines will have access to vaccines produced by an Argentine company, recognized as a model in the region. Through its commitment to vaccine production and distribution, Sinergium Biotech can help ensure that a greater number of Argentines receive the Hepatitis A vaccine and other essential vaccines. This not only protects individuals from potentially serious diseases, but also contributes to herd immunity and overall public health.
About Sinovac:
Sinovac Biotech is a Chinese biopharmaceutical company that focuses on the research, development, manufacturing and marketing of vaccines, including Healive (hepatitis A). The company is headquartered in Haidian District, Beijing.
Last Friday we had the honor of receiving Jarbas Barbosa Da Silva Jr, General Director of the Pan American Health Organization and Regional Director for the Americas of the World Health Organization, at our facilities, along with a delegation of PAHO advisors, where signed a new agreement within the program to promote the development and production of vaccines based on mRNA technology. This development in the country will contribute to reducing the region’s external dependence and moving towards more equitable access to vaccines and innovative health technologies in Latin America and the Caribbean.
During 24-26 October, we had the privilege of hosting a visit from the Medicines Patent Pool (MPP) as part of the mRNA Technology Transfer Programme. This visit marked a significant step in our ongoing efforts to strengthen our capabilities in the field of mRNA technology.
The objectives of this visit encompassed several key areas: Facility Assessment: Our visitors assessed the current state of our plant, gaining a comprehensive understanding of our facilities, quality control systems, equipment, personnel, and regulatory compliance. Strategy Analysis: A rigorous analysis of Sinergium’s strategy for implementing mRNA technology was conducted, focusing on the steps taken to establish and advance on our mRNA platform. Action Plan Development: A crucial outcome of this visit is the collaborative development of an action plan. This plan will outlines specific activities, budget allocations, and timelines, all aimed at ensuring that Sinergium is well-prepared to receive and implement mRNA technology effectively.
Our team remains dedicated to becoming the leading mRNA vaccine producer in Argentina. The knowledge and insights gained from this visit are invaluable in helping us achieve this goal. We extend our gratitude to the Medicines Patent Pool(MPP) for their support and guidance throughout this endeavor.
You can learn more about this Programme by visiting the following links: www.mrnaprogramme.org
About SINERGIUM Biotech– Argentine biopharmaceutical company is specialized in the research, development, production and commercialization of vaccines and highly complex biopharmaceutical products. https://lnkd.in/d-cMPhRf
About MPP – The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. https://lnkd.in/dJvmU_V
Buenos Aires, October 7, 2023 (PAHO/WHO). The Director of the Pan American Health Organization (PAHO), Jarbas Barbosa, participated yesterday in the closing of the 5th World Summit on Mental Health where he emphasized the importance of integrating this issue into all public policies in order to address social determinants, economic and environmental aspects of mental health.
“The incorporation of mental health in all policies will reinforce recovery efforts from the pandemic and will contribute to rebuilding better health systems and services,” the PAHO Director said in Buenos Aires.
Dr. Barbosa highlighted that “investing in the development of human capital and social protection is essential to promote and protect mental health” while considering it necessary to “increase investment in community-based care” to improve the recovery results of the people with mental health problems.
He also indicated that childhood and adolescence “constitute an important window of opportunity to promote and protect good mental health, identify people at risk and provide early care.” He also highlighted old age, a time of life when “older adults also face significant mental health risks.” For this, “the expansion of community-based services and care, as well as integrated networks of services and support beyond the health sector,” is essential.
Another of the axes that he highlighted was the value of mental health and psychosocial support as essential components in the response to public health emergencies, humanitarian crises, and the present and future threats of climate change.
“I am confident that if we, as a global community, work together, we can build on the momentum generated by this summit to transform mental health for the good of all, including future generations,” concluded the PAHO Director.
mRNA technology transfer
In the morning, Dr. Barbosa visited the Sinergium Biotech plant in order to see the facilities and sign the cooperation agreement for the production of mRNA vaccines in Argentina, within the framework of the Regional Platform for the innovation and production of vaccines and other PAHO health technologies.
This cooperation is complemented by the World Health Organization (WHO) and Medicines Patent Pool (MPP) technology transfer program for the development of mRNA vaccines in low- and middle-income countries. Thus, in September 2021, PAHO/WHO announced that Sinergium Biotech, from Argentina, and the Bio-Manguinhos Institute of Immunobiology, from Brazil, were selected to join the WHO network for technology transfer for the mRNA vaccines.
The agreement was also signed on Monday with national authorities so that the National Administration of Laboratories and Health Institutes “Dr. Carlos Malbrán” (ANLIS-Malbrán), dependent on the Ministry of Health of Argentina, is part of the production chain through the development of lipid nanoparticles, essential inputs in the production of mRNA vaccines. In addition, it includes the National Agency for the Promotion of Research, Technological Development and Innovation (R&D+i Agency) which will contribute to the promotion of studies and the creation of capabilities in the country.
These activities culminated yesterday in the official visit to Argentina of the Director of PAHO, which began on Monday and included a work agenda that included meetings with national and jurisdictional authorities in the field of government, health, science and technology, as well as with members of the Commission for Social Action and Public Health of the Chamber of Deputies of the National Congress where Dr. Barbosa advocated for Argentina’s ratification of the Framework Convention for Tobacco Control (FCTC) of the World Health Organization (WHO).
In addition, during the week the Director of PAHO toured the ANLIS – Malbrán laboratories and the vaccination center and the facilities of the Garrahan Hospital. He also announced the creation of the Pharmaceutical Services Network of the Americas (RedSFar), presented a new tool to evaluate the quality of the provision of pharmaceutical services, held a meeting with representatives of the PAHO Collaborating Centers in Argentina, and spoke at a conference on the challenge of health systems organized by the Latin American Association of Private Health Systems (ALAMI).
Buenos Aires, October 3, 2023 (PAHO/WHO) – The Director of the Pan American Health Organization (PAHO), Dr. Jarbas Barbosa, held a meeting today with the President of Argentina, Alberto Fernández, in which they highlighted the need to strengthen the production of vaccines and medical supplies in Latin America and the Caribbean, in order to move towards regional self-sufficiency.
In this sense, Dr. Barbosa highlighted the agreement signed yesterday with health, science and technology authorities of the country for the transfer of technology to the National Administration of Laboratories and Health Institutes (ANLIS-Malbrán), in order to develop nanoparticles of lipids, essential inputs in the production of mRNA vaccines.
Argentina, through the biopharmaceutical company Sinergium Biotech, was selected in 2021 by the WHO to receive technology transfer for the production of mRNA vaccines, which may eventually be offered to other countries in the region through the Regional Revolving Funds of the WHO. OPS.
Now, ANLIS-Malbrán will contribute to the production chain with the development of nanoparticles. In addition, the National Agency for the Promotion of Research, Technological Development and Innovation (R&D&i Agency) will join in by promoting studies and creating capabilities.
The future development of these vaccines and supplies in the country will help reduce the region’s external dependence and move towards more equitable access to vaccines.
A few days after the inauguration in the Autonomous City of Buenos Aires of the V World Summit on Mental Health, the Director of PAHO and the Argentine President analyzed the challenges in the matter after the impact of the COVID-19 pandemic, and the progress of the country from the perspective of human rights and inclusion.
The PAHO/WHO representative in Argentina, Eva Jané Llopis, and the Minister of Health, Carla Vizzotti, also participated in the meeting at the Casa Rosada.
The official visit to Argentina of the Director of PAHO, which began yesterday, has a work agenda that includes meetings with health, science and technology, and defense authorities, as well as meetings with parliamentarians and representatives of the United Nations and the centers PAHO collaborators in the country. It also includes visits to the Garrahan Hospital and the ANLIS-Malbrán and Sinergium Biotech laboratories.
Furthermore, as part of the official visit of the PAHO director to Argentina, Vizzotti led a meeting with him together with authorities from ANLIS Malbrán, ANMAT and ANLAP in which they worked on axes prioritized by the national government on health research and development.
Within the framework of a high-level meeting with the director of the Pan American Health Organization (PAHO), Jarbas Barbosa da Silva, to address the national health research and production policy and the experience of Argentina’s incorporation into the HUB for the transfer of technology from the WHO, the Minister of Health of the Nation, Carla Vizzotti, signed a technical cooperation agreement between the portfolio she directs, the National Administration of Laboratories and Health Institutes (ANLIS) “Dr. Carlos Malbrán”, the National Agency for the Promotion of Research, Technological Development and Innovation (R&D&I), the biopharmaceutical company Sinergium Biotech and the PAHO with the aim of strengthening and increasing vaccine development and production capacities and other quality, safe and effective health technologies in Argentina and the Region of the Americas.
“It is extremely important that Argentina has been selected along with Brazil to carry out the technology transfer of a messenger RNA vaccine,” highlighted Vizzotti, while maintaining that “after a long year of work together with the R&D+ Agency “i, the Malbrán Institute, the Ministry of Health and a private production plant reached the signing of this agreement that will allow us to advance with equipment, strengthening and the transfer of the necessary technology to benefit the region.”
“With this agreement we are strengthening the mRNA vaccine production ecosystem and giving greater sustainability” to the PAHO/WHO technology transfer project in Argentina, stated the director of PAHO/WHO, Jarbas Barbosa. In addition, he added that the future development of these vaccines in the country “will help reduce the region’s external dependence on this technology and move towards more equitable access.”
In turn, the Minister of Science, Technology and Innovation, Daniel Filmus, highlighted that the vaccine “represents a before and after for the history of clinical studies in our country because it is the first time they have been carried out with our own vaccine. For us, it is also very important not only the possibility of substituting imports but also the ability to export, for which we have already started conversations. The ARVAC-Cecilia Grierson vaccine is also a successful case of public-private coordination between the Ministries of Science and Health, the R&D&I Agency, the National University of San Martín (UNSAM), CONICET and the laboratory. “Cassara.”
The R+D+i president, Fernando Peirano, stated that “Argentina has guaranteed and universalized the right to health and this can also be a good engine to value our industrial capacity, our scientific capacity to develop new solutions and it is That is why we have been accompanying the process. This agenda must aim to reach the ultimate consequences, which is neither more nor less than becoming a new treatment or a new health solution.”
Finally, the Secretary of Industry and Productive Development, José Ignacio de Mendiguren, highlighted that “for Minister Sergio Massa the articulation between science, health and industry is fundamental to consolidate a development model centered on import substitution and greater presence of Argentine work and innovation in the world.” And he added: “Something that the pandemic taught us was the importance of that synergy, which is why from the Ministry of Economy we have specific financing and development plans, in absolute coordination with the ministries of Health and Science, so that all these efforts are sustainable.”
It is worth remembering that in 2021, the WHO carried out a global call for expressions of interest in which manufacturers and public and private research institutions were invited to contribute to the establishment of technology transfer centers for messenger RNA vaccines against COVID-19. 19 in emerging economies. In this context, for the development and production of mRNA vaccines in Latin America, two regional centers were selected, both in Argentina and Brazil, with the private sector biopharmaceutical company Sinergium Biotech being chosen in Argentina.
Meeting with authorities from ANLIS Malbrán, ANMAT and ANLAP
During the day, Vizzotti led, together with the director of PAHO, a meeting with the head of ANLIS Malbrán, Pascual Fidelio, the head of the National Administration of Medicines, Food and Medical Technology (ANMAT), Manuel Limeres, and the president of the National Agency of Public Laboratories (ANLAP), Ana Lía Allemand, in which prioritized axes in health research and development were addressed, such as the production of messenger RNA vaccines, the transfer of new genomic and proteomic technologies to the countries of the region, the development of new Collaborating Centers and Reference Laboratories, and the advances of the Federal Network of Genomics and Bioinformatics of Argentina.
In addition, together with the WHO/PAHO representative in Argentina, Eva Jané Llopis, they took a tour of ANLIS-Malbrán where they visited the International Workshop on Poliovirus Sanger Sequencing, sponsored by PAHO.
Previously, they participated in the opening of the 9th Meeting of the ANLAP Executive Committee, where the management report and the research work of the scholarship recipients of the doctoral and postdoctoral scholarships co-financed by the National Scientific and Technical Research Council were presented. (CONICET) and the ANLAP of the 2020-2021 cohorts.
President Alberto Fernández received today the Director of the Pan American Health Organization (PAHO), Jarbas Barbosa, and the Minister of Health, Carla Vizzotti, within the framework of the recent cooperation agreement that Argentina signed with that public health agency to increase vaccine development and production capacities, and two days before the start of the 5th World Mental Health Summit in Buenos Aires.
During the meeting, in which the PAHO Representative in Argentina, Eva Llopis, also participated, the president appreciated that the health portfolio worked together with the National Administration of Laboratories and Health Institutes (ANLIS) “Dr. Carlos Malbrán”, the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i) and the biopharmaceutical company Sinergium Biotech, signed an agreement this week for the production of vaccines and other health technologies.
For Barbosa, “vaccine production remains very centralized in developed countries,” which is why he congratulated “the effort that Argentina, the public sector and the private sector, are making to produce vaccines that will serve the population of Argentina and of Latin America and the Caribbean”.
The agreement reached with PAHO aims to advance with equipment and strengthen the transfer of technology necessary to develop and produce messenger RNA vaccines in the region.
The development of these vaccines in the country, through the coordination between science, health and industry, will allow progress towards more equitable access and reduce the region’s external dependence on this technology, with a greater presence of Argentine work and innovation in the world.
Meanwhile, the President will open this Thursday the 5th World Mental Health Summit, which for the first time will be held in Latin America with the presence, in addition to Barbosa, of the Director General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus. , Ministers of Health from around the world, national, regional and international experts in mental health and representatives of user associations and civil society organizations.
The mRNA technology transfer programme is a global initiative that aims to improve health and health security by establishing sustainable, locally owned mRNA manufacturing capabilities in and for low- and middle-income countries (LMICs).The programme is based around a technology transfer “hub” Afrigen, which is located in South Africa. They will provide the technology development, training and technology transfer, and currently 15 programme partners in LMICs across the world are receiving training and technology from the hub and will then produce and sell products commercially. Its core concept is empowerment.
Initially the programme is focusing on mRNA vaccines against COVID-19. However, the programme is designed to encourage the development of other mRNA vaccines and therapeutics against important diseases that threaten LMICs, thereby ensuring the capacity built by the project is sustained and available to combat the next pandemic.
The special distinctions are dedicated to the strengthening of SMEs, tourism, contribution to health and animal welfare certification.
The 2023 Fortuna Award for Contribution to Public Health was awarded to Sinergium Biotech. Its CEO, Alejandro Gil, received the award from Martín Cabrales, vice president of Cabrales.
“The motto of our company is ‘We take care of health, we preserve life’. We are a young company, we were born with the flu pandemic and we work developing technology to improve the health of Argentines,” said Alejandro Gil.
And he added: “We thank Editorial Perfil and Fortuna Magazine, it is a source of pride for those of us who make Sinergium.”
Sinergium Biotech is an Argentine biopharmaceutical company specialized in the research, development, production and marketing of vaccines and highly complex products.
Fortune Awards
Every year, Fortuna magazine, from Editorial Perfil, awards those who stood out the most in business activity in Argentina in various sectors such as food, electricity and oil and industries such as automotive, telecommunications and banks.
In this edition, the awards arise from the evaluation carried out by Aurum Valores, through a team led by Pablo Repetto, Head of Research at Aurum.
The representatives of the organization did so together with directors of the Pan American Health Organization. They met with national authorities and with the team that is carrying out the technology transfer process for said production.
The World Health Organization (WHO) announced in 2021 the creation of a technology transfer center, Afrigen, located in South Africa, which seeks to share technical knowledge to low- and middle-income countries to boost the capacity to produce messenger RNA vaccines.
This initiative led to calls of interest from companies worldwide. América Sinergium Biotech, in Argentina, and the Fiocruz-Biomanghinos Institute, in Brazil, were the only two centers selected within a competitive evaluation with more than 30 bidders, due to their experience in vaccine production and their level of technology and human resources.
In March 2022, the Argentine team was the first to receive training at the specialized center, which delved into the laboratory-scale mRNA manufacturing process, including the formulation of lipid nanoparticles and data analysis, as well as the production and quality control of the finished product. After the visit, work began locally at the Sinergium Biotech plant, managing to replicate the training received in Afrigen.
“The project lays the foundations for the implementation of a regional collaboration that takes advantage of the resources and knowledge of each participant with the ultimate objective of expanding Latin America’s capacity in the production of vaccines with mRNA technology,” said Germán Sánchez Alberti, Manager. of Development and Innovation of Sinergium Biotech. The WHO has developed a vaccine prototype that will enter the clinical testing phase next year.
The visit to the mRNA vaccine development and production center
A mission of delegates from the Pan American Health Organization (PAHO), the WHO and the Medicines Patent Pool met with national health authorities and with the Sinergium Biotech team (Insud’s human vaccine company), which is carrying out the process of technological transfer for the production of messenger RNA (mRNA) vaccines in the country for regional destination.
During the meeting, the PAHO representative in Argentina, Eva Jané Llopis; the Minister of Health of the Nation, Carla Vizzotti; the senior technical officer at the WHO, Claudia Nannei, the Business Development Director of Sinergium Biotech, Fernando Lobos, and other officials evaluated the progress of the transfer program and analyzed the possibilities that this technology offers for the development of vaccines against the virus SARS-CoV-2 as well as other priority pathogens for the region, and biotherapeutic products.
“The need for self-sufficiency in the region during the pandemic woke us all up,” said Jané Llopis and added: “It is a challenge and we will continue working from PAHO together with the Ministry of Health of the Nation and all the actors, to face the challenges.” pandemics that may appear, and at the same time go further and investigate the different opportunities that messenger RNA technology allows and offer them to the entire region of the Americas.”
The PAHO representative in Argentina highlighted the country’s leadership in the region in health matters and its ability to face this new challenge and celebrated the Argentine laboratory’s goal of “becoming a pioneer in the production of mRNA vaccines” among the 15 chosen centers. in different places around the world.
The opinion of those who were at the meeting
The minister referred to the importance of working together and with a strategic perspective and expressed the need to “develop sustainable public policies aimed at promoting the development of vaccines and other biotechnological products, expanding our production capacities for these strategic inputs and contributing to regional health self-sufficiency”.
For his part, Lobos mentioned the value of the collaboration that exists between the different national and international actors, and “of PAHO, which was on par from the beginning of the project to have the potential to move forward firmly and faster.” The director of the laboratory also referred to the importance of choosing priority diseases for the region and Argentina in order to demonstrate the operation of the platform, and achieve a strong impact on the health of the entire region of the Americas.
Currently, the Sinergium Biotech laboratory continues to forge a strategic relationship with PAHO to supply essential vaccines for the region, participating in flu vaccine tenders and supplying them for 3 years, making this project one more step towards integration. regional vaccine production center for the americas.
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