Fully-owned state of the art manufacturing process for just in time delivery
To successfully bring individualized immunotherapies to patients, it is critical to control the manufacturing and supply processes. We decided to invest early in scaling our in-house capabilities and have established the manufacturing and production together with our digital factory partner Siemens to develop a process for the fully-automated, on-demand production of mRNA therapies.
We operate three GMP-certified manufacturing facilities in Germany, where we manufacture mRNA therapeutics and engineered cell therapies for our own pipeline and for external customers. We operate a fourth facility in Germany where we manufacture custom peptides to support our extensive immunomonitoring activities within our development programs. Our subsidiary BioNTech Innovative Manufacturing Services GmbH, or BioNTech IMFS, has been manufacturing GMP-certified cellular products since 1999, was granted its first GMP license for manufacturing mRNA in 2011 and has been manufacturing individualized mRNA products since 2014. We have expanded our capability to produce and supply drug products to support clinical development of our, and our collaborators’, product candidates. To date, we have manufactured over 500 drug substance batches in our manufacturing facilities.
Building manufacturing capabilities for success
Our approach has been to proactively build capacity in anticipation of demand from internal research and development, as well as from our collaborators. We have done so by continuing to make significant investments in manufacturing infrastructure and increasingly expanding our capacity to manufacture mRNA, viral vectors, cellular products and peptides. We believe the development and optimization of our manufacturing processes in parallel to drug development is crucial to our success.