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 our COVID-19 vaccine
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.
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.
Do you know what's in our COVID-19 vaccine and why?
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 - 200 of them in 24/7 shifts to ensure production
individual quality control tests for each finished vaccine batch
documents to ensure the safety and quality of the production process
How are we manufacturing our COVID-19 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 - building sustainable solutions for the African continent
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. The solution is intended to improve vaccine supply in Africa.
The manufacturing solution consists of one drug substance and one formulation module. Each module is built of six ISO sized containers. Each BioNTainer is a clean room which BioNTech equips with state-of-the-art manufacturing solutions. Together, two modules require 800 sqm of space and offer an estimated initial capacity of, for example, up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year.
The BioNTainer 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.
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. We will initially staff and operate the facilities to enable the safe and rapid initiation of the production of mRNA-based vaccine doses under stringent good manufacturing processes in order to prepare for the transfer of know-how to local partners to enable independent operation. This solution is an important step to improve global vaccine supply.
Establishing regional headquarters in Asia
We have plans to expand our global footprint to Asia with the establishment of our regional headquarters for Southeast Asia in Singapore. In addition to selecting Singapore as BioNTech’s future regional Asia headquarters, we plan to establish a fully integrated mRNA manufacturing facility in Singapore with support from the Singapore Economic Development Board. The new facility will provide regional and global supply capacity of BioNTech’s growing pipeline of mRNA-based product candidates, as well as a rapid response production capability for Southeast Asia to address potential pandemic threats.