Fully owned state-of-the-art manufacturing facilities for just-in-time delivery and scalable production
To successfully bring individualized immunotherapies to patients and vaccines to people around the world, it is crucial to have in-house manufacturing capabilities. We have several manufacturing sites capable of developing fully automated production processes for on-demand production of our therapies and vaccines. In addition, we have developed a shippable, modular and turnkey mRNA manufacturing facility, called BioNTainer, to support a decentralized and scalable vaccine production that addresses local needs. The solution is intended to improve vaccine supply with Africa, in Africa for Africa.
Manufacturing of mRNA-based vaccine products and candidates
Supplying the world with a safe and effective vaccine requires a widespread network. Large parts of the production take place in-house at our principal manufacturing facility in Marburg. Additionally, we trust in our strong partnerships with companies that contribute their expertise to various steps of the production process.
Manufacturing sites
The production of mRNA vaccines requires highly specialized production facilities that meet the necessary quality requirements. We have built our capabilities over 10 years and we are continuously increasing our capacity.
Facts and figures about our vaccine production in Marburg and our modular mRNA manufacturing solution BioNTainer:
steps from beginning of the batch to bulk fitting
employees in Marburg
individual quality control tests for each finished vaccine batch
documents to ensure the safety and quality of the production process
How are we manufacturing an mRNA-LNP-based vaccine?
mRNA can be produced at a large scale in a short manufacturing cycle and allows for a sizable scale-up as well as quick adaption of manufacturing aimed at a worldwide supply.
To manufacture mRNA at a large scale, we use biochemical reactions, similar to those occurring in every cell of the human body.
This process is called in vitro transcription
Following production, the mRNA is purified by using a proprietary purification process and subsequently concentrated.
To ensure safe and correct delivery, the mRNA is encapsulated within a mixture of lipids that form lipid nanoparticles (LNP).
The final manufacturing step is a sterile filtration and filling of the vaccine into vials.
Manufacturing of our immunotherapies
We are a fully integrated immunotherapy powerhouse building and advancing our know-how to manufacture the breadth of therapeutic candidates on a commercial scale, and striving to ensure equitable access to our programs.
The full potential of mRNA therapeutics
mRNA vaccines are a potent new class of drugs that have the potential to help people around the world. We want to harness the full potential of this new technology as it holds promise to replace, or complement, traditional treatments for a range of infectious diseases and cancer. With our individualized cancer therapy platforms, iNeST and FixVac, we are developing a completely novel approach for how we treat cancer. It requires a very specialized production process to provide the right cancer treatment for each person in a timely manner, while also being able to reach patients globally.
Manufacturing beyond mRNA
Our therapeutic portfolio includes four different drug classes. Since our foundation we have been focused on building the right manufacturing capabilities for each drug class bringing together the right experts to ensure supply both on a clinical and commercial scale.
Building manufacturing capabilities for success – a global approach
Our approach is to proactively build capacity in anticipation of demand from our own research and development activities that we are conducting both alone and with collaborators. We believe that the development and optimization of our manufacturing processes, in parallel to drug development, is crucial to our success. This includes the development of solutions that ensure equitable access to our therapeutic programs, particularly in low-income countries and regions with limited infrastructure.
BioNTainers – a new solution to manufacture mRNA-based products worldwide
In February 2022, we introduced our approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution, the BioNTainer. This is a solution we believe is also capable of improving vaccine supply in Africa. Other use cases include, for example, research and development of investigational medicines based on mRNA.
The manufacturing solution consists of one drug substance and one formulation module. Each module is built of at least six ISO sized containers. Each BioNTainer is a high-tech clean room which BioNTech equips with state-of-the-art manufacturing solutions.
In June 2022, we broke ground for our initial African mRNA manufacturing facility in Kigali, Rwanda. The Rwandan facility will be initially equipped with two BioNTainers, one for the production of mRNA and one for the production of the formulated bulk drug product. The containers for the first BioNTainer have arrived in Kigali in March 2023.
Each BioNTainer is intended to become a node in a decentralized and robust African end-to-end manufacturing network, aiming to offer greater independence and faster vaccine supply within the African Union. They will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, for example, our COVID-19 vaccine and our investigational malaria and tuberculosis vaccines, if they are successfully developed, approved, and authorized by regulatory authorities.
We also plan to set up BioNTainer-based manufacturing facilities in Australia and Israel to support research and development of novel medicines in collaboration with world-class scientists in the respective countries and disciplines.
Expansion of footprint in Asia
As part of our Asia-Pacific strategy, we aim to develop, manufacture and broaden the access to innovative medicines in Asia, with a focus on treatments addressing the region’s most common types of cancer.
To this end, we announced plans to establish our regional headquarters for Southeast Asia in Singapore. In November 2022, we announced that our Singapore affiliate BioNTech Pharmaceuticals Asia Pacific Pte. Ltd. had entered into an agreement with Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. to acquire one of its GMP-certified manufacturing facilities. Supported by the Singapore Economic Development Board, the facility will not only serve as BioNTech’s Regional Headquarters but also become its first mRNA manufacturing facility in Singapore.
In addition, in December 2022 we announced plans to accelerate and broaden the clinical development of BioNTech’s cancer immunotherapy pipeline in the Asia-Pacific region by expanding our clinical footprint to East Asia. The first regional clinical trial sites for our mRNA-based cancer immunotherapies are planned to be activated in Taiwan to initially evaluate BioNTech’s cancer product candidate BNT113 against head and neck cancer. As part of these plans, BioNTech is collaborating with the YongLin Healthcare Foundation and, in November 2022, signed a Memorandum of Understanding with Retain Biotech Corp., a Taiwan-based organization that is sponsored by the YongLin Healthcare Foundation and engaged in precision medicine, genomic medicine and cell therapy in oncology.
