(MENAFN- GlobeNewsWire – Nasdaq) Set-up of first BioNTainer as high-tech manufacturing solution for mRNA medicines is a critical step in establishing a resilient vaccine ecosystem in Africa and future pandemic preparedness BioNTech plans to complete all buildings at the Kigali site and start local training of specialized personnel in the facility in 2024, with test mRNA production for process validation to be initiated in 2025 Upon successful validation, the Kigali facility will serve as a lighthouse project for subsequent mRNA-based vaccine manufacturing facilities of smaller or larger scale to support clinical development or commercial-scale production in line with local or regional demand In addition, BioNTech is progressing the development of mRNA vaccine candidates for infectious diseases with high medical need, including vaccine candidates against tuberculosis, malaria, and HIV, as well as against infectious diseases with pandemic potential, such as mpox. Upon successful development and approval, these vaccines are intended for production at the newly established site On invitation by H.E. President Paul Kagame of Rwanda, Heads of State and Government from Africa and around the world, leadership of the African Union and European Union, as well as from WHO, Africa CDC and CEPI attended the official inauguration of the BioNTech site in Kigali
KIGALI, Rwanda, Dec. 18, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) has taken the next step in building mRNA vaccine production functions in Africa with the inauguration of the Kigali, Rwanda Location. The inauguration took as an example the status quo of the first production unit called BioNtainer. This effort is one of multiple projects by BioNTech to help build a sustainable and resilient African vaccine ecosystem and equitable access to new medicines globally. : encompassing studies and development, clinical trials, production, and local education of specialized personnel.
At a full-day convention titled “Working Together to Advance Vaccine Equity in Africa” that preceded the site’s inauguration, BioNTech met with representatives from the World Health Organization (“WHO”), the Coalition for Epidemic Preparedness Innovations (“CEPI”), Africa Centers for Disease Control and Prevention (“Africa CDC”), the Rwanda Food and Drug Administration (“Rwanda FDA”), the Health Emergency Preparedness and Response Authority (“HERA”), the Bill & Melinda Gates Foundation, and the South African Department of Health. Productos. La Regulatory Authority will discuss the opportunities and challenging situations of building a sustainable and resilient vaccine ecosystem in Africa. At the invitation of His Excellency President Paul Kagame of Rwanda, Heads of State and Government from around the world, the top leaders of the African Union, the European Union, as well as WHO and CEPI attended the opening rite of the BioNTech site. The company’s production facility in Kigali has the potential to become the first commercial-scale mRNA production facility on the continent.
The facility is based on the company’s high-tech, virtual modular production assemblies called BioNTainers. They are designed to manufacture a variety of mRNA-based vaccines. BioNTainers are also designed to be updated regularly, as BioNTech needs them to remain one of the most complicated mRNA production facilities in the world. The production site will first be supplied with two BioNTainers. The boxes of the first BioNTainer, recently installed in the production corridor and which will be used to manufacture mRNA as a pharmacological substance, have arrived. in Kigali in March 2023. La second BioNtainer unit will be used to manufacture the bulk formulated drug and will be in a position to ship it to the Rwanda site in the first quarter of 2024.
The Kigali production facility has been fully funded to date by BioNTech. The Company has committed a total investment of approximately $150 million for the entire site structure, adding production units. The total site is approximately 35,000 square meters in length and will employ approximately one hundred workers once it is fully compatible with the national one. In 2024, BioNTech plans to complete all of the site’s buildings, adding a warehouse, offices, and quality laboratories. The company anticipates that, following the local training of the specialized body of workers in 2024, it will be able to start generating batches of mandatory mRNA vaccines for validation of the procedure in 2025. The facility is intended to manufacture vaccines tailored to the wishes of African Union members. . Its production capacity depends on the mRNA product being manufactured and its various points such as dosage and formulation. For example, BioNTech could manufacture up to 50 million doses per year of a product with an RNA process similar to that of the Pfizer-BioNTech COVID-19 vaccine.
In line with the continent’s and partner countries’ needs, BioNTech is committed to establishing additional manufacturing facilities in Africa upon the successful validation of the facility in Kigali, which serves as a lighthouse project. Compared to the facility in Kigali, additional sites could be designed as larger facilities providing increased commercial-scale manufacturing capacities in Africa, or they could be smaller and specialized in the manufacture of batches for the clinical evaluation of product candidates.
To the creation of a sustainable vaccine ecosystem in Africa, BioNTech is advancing the progression of prophylactic mRNA vaccines targeting infectious diseases such as tuberculosis, malaria and HIV, and is also focusing on diseases with epidemic and pandemic potential, adding mpox. Vaccination systems against tuberculosis and malaria are already in place in South Africa and the United States, respectively. BioNTech plans to conduct clinical trials in Africa for malaria, tuberculosis and HIV vaccine applicants in 2024. Malaria, tuberculosis and HIV are widespread in Africa, causing more than two million deaths a year, adding to a peak in infant mortality. If it is indeed developed and approved through regulatory authorities, BioNTech plans to provide low-income countries with access to the four prophylactic vaccines at a non-profit price.
While in Kigali, Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, met with His Excellency Macky Sall, President of the Republic of Senegal, and discussed developing a potential research partnership between BioNTech and the Institut Pasteur de Dakar with a focus on infectious diseases relevant to the African continent.
The multimedia fabrics for the inauguration of the venue can be obtained at the following link, which will be updated later with more material:
About the inauguration ceremony: Attendees of the site inauguration ceremony included H.E. Paul Kagame, President of the Republic of Rwanda, H.E. Macky Sall, President of the Republic of Senegal, H.E. Nana Akufo-Addo, President of the Republic of Ghana, Hon. Mia Amor Mottley, Prime Minister of Barbados, H.E. Ursula von der Leyen, President of the European Commission, African Union Chairperson Moussa Faki Mahamat of the African Union Commission, Hon. Annalena Baerbock, Federal Minister of Foreign Affairs of the Federal Republic of Germany, Hon. Dr Mathume Joseph Phaala, Minister of Health of the Republic of South Africa and Ambassador Gervais Abayeho, Minister of East Africa Community Affairs of the Republic of Burundi. In attendance from development finance institutions were Dr Akinwumi Adesina, President of the African Development Bank and European Investment Bank Vice President Gelsomina Vigliotti.
Quotations delivered at the opening ceremony:
HE. Paul Kagame, President of the Republic of Rwanda: “Inequalities in immunization have hit Africa hard during the pandemic. But BioNTech’s partnership with Africa demonstrates that vaccine generation can be democratized, so that Africa is fit and resilient no matter what happens in the future.
Macky Sall, President of the Republic of Senegal: “This is a special day for Africa. BioNTech has taken a vital step toward greater vaccine equity. It is a wonderful example of a company acting with wonderful social responsibility. I am absolutely into what BioNTech is doing in Rwanda and we look forward to advancing a study partnership in Senegal with the Pasteur Institute in Dakar. “
Ursula von der Leyen, President of the European Commission: “The opening of BioNTech’s first site in Africa in Kigali is a vital step towards African vaccine sovereignty. Manufacturing mRNA-based vaccines in Africa for others in Africa will be a game-changer in the fight against diseases and pandemics. The EU is proud to work with Rwanda and BioNTech to expand a colorful biopharmaceutical industry on the continent. Global Gateway, Europe’s investment strategy, invests in Africa’s vaccine production and the right skills, jobs and capabilities to drive fitness innovation across the continent.
African Union Chairperson Moussa Faki Mahamat of the African Union Commission: “This is a vital day for Africa. The continent is committed to expanding the accessibility and quality of vaccines and other medicines needed to make them available to all Africans. This is also the propósito. de the African Medicines Agency, based here in Kigali. In this regard, we believe that this BioNTech and AMA facility will contribute to our collective vision of a self-reliant Africa. Creating a high-quality regulatory environment and ensuring vaccine independence are critical to our long-term ability to prepare for, respond to, and recover from pandemics. Working together to advance vaccine equity in Africa remains our priority.
Hon. Annalena Baerbock, Federal Minister of Foreign Affairs of the Federal Republic of Germany:“ The road to a fair international health architecture is not a short-distance race, but a team marathon. That is why Team Europe supports the goal of Africa’s own vaccine production – from conception to injection. Today, only one in 100 of the vaccine doses administered in Africa is actually produced there; by 2040, this figure is set to be 60 times higher. Global Gateway is making this possible by providing 1.2 billion euro by 2027, with 550 million euro coming from Germany alone. The opening of Africa’s first mRNA vaccine factory in Rwanda by BioNTech is not yet the finishing line – but it is a real milestone and a source of hope for millions.”
Dr. Jean Kaseya, Director General of the Africa Centers for Disease Prevention and Control (Africa CDC): “The local production program represents Africa’s second independence, and the inauguration of BioNTainer’s production facility represents a vital milestone in our collective efforts to develop vaccines. production capacity, physical security, and access to life-saving vaccines across the African continent.
Prof. Ugur Sahin, M. D. , CEO and Co-Founder of BioNTech: “We are committed to building a sustainable mRNA vaccine ecosystem in Africa, focusing on developing mRNA vaccines against infectious diseases with medical best wishes and forging state-of-the-art solutions. . for local production. Today’s groundbreaking occasion, the construction of the first “BioNtainer” module for mRNA production, is a milestone in this journey. Together with our partners, we are moving towards our first commercial-scale mRNA installation in Africa, a cornerstone of our shared vision. of a long-term sustainable health plan. I would like to express my gratitude to our local and foreign partners for their contributions to this joint effort, as well as to the entire BioNTech team for their committed work that made this inauguration possible.
Sierk Poetting, Ph. D. , BioNTech’s Chief Operating Officer: “The BioNTainer-based facility goes beyond an undeniable physical structure. It represents the concept of revolutionizing pharmaceutical production by combining virtual generation with standardized mRNA production. BioNTainers are designed to deliver consistent production processes that can be implemented globally and tailored to regional needs. We’ve configured the BioNTainers to be up-to-date in order to remain one of the most complex mRNA production facilities in the world.
About BioNTech Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer. For more information, please visit .
BioNTech’s Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the ability of BioNTech to produce, deliver and install mRNA container manufacturing facilities for the African continent, including the ability to meet all necessary infrastructure, technology and regulatory requirements within projected timelines; BioNTech’s plans to update the BioNTainers; BioNTech’s ability to reach agreements with potential collaboration partners in Africa, including a potential research partnership with the Institut Pasteur de Dakar in Senegal; the development of quality control capabilities; the scale-up of local know-how and training in Africa; BioNTech’s malaria, tuberculosis, HIV, mpox and other infectious disease vaccine development programs (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply agreements and the timing of delivery of doses thereunder, efforts to help ensure global equitable access to approved vaccines, the anticipated timing of regulatory submissions, regulatory approvals or authorizations, and anticipated manufacturing, distribution and supply); timing for selecting clinical candidates for these programs and the commencement of clinical trials, as well as any data readouts; the nature of the collaboration with the African Union, the Africa CDC, the WHO, and other parties; the development of sustainable RNA vaccine capacities, production and supply solutions in Africa and the nature, timing, and feasibility of these solutions. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the potential safety and efficacy of the product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the ability to produce comparable clinical results in future clinical trials; potential delays in the establishment of the BioNTainers and BioNTech operations in Africa due to unforeseen developments, including, but not limited to, global supply chain issues; and the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved.
You deserve the perils and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended September 30, 2023, and BioNTech’s upcoming filings with the SEC, found on the SEC’s online page at ArrayExcept. As required by law, BioNTech disclaims any objective or duty to update or revise any forward-looking statements contained in this press release, whether as a result of new information, long-term developments or otherwise. These forward-looking statements are based on BioNTech’s existing expectations. and speak only from the date of the present.
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