On Oct. 7, 2020, Rentschler Biopharma announced an agreement to serve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP (current good manufacturing practice) drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, and is currently in a global Phase 3 clinical trial.

Under the agreement, Rentschler Biopharma will be responsible for downstream processing to provide highly purified drug substance. Process and product-related impurities will be effectively removed from the intermediate pool, which has been previously derived from mRNA synthesis. This is an important step in ensuring the safety and tolerability of a vaccine for use in humans, while at the same time maximizing the amount of mRNA harvested from the initial production process. Rentschler Biopharma will produce purified drug substance at its headquarters in Laupheim, Germany.

BioNTech and Rentschler Biopharma will use an innovative business model that is well suited for novel, urgently needed technologies and allows maximum flexibility to address BioNTech’s development and manufacturing requirements. In addition to large-scale production services for the COVID-19 vaccine, the agreement also provides for small-batch manufacturing of BioNTech’s other RNA programs for use in clinical trials.