In addition to the COVID-19 vaccine, the agreement also provides for small-batch manufacturing of BioNTech’s other RNA programs for use in clinical trials
Rentschler Biopharma has announced an agreement to serve as CDMO partner for BioNTech.
As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, currently in a global Phase 3 clinical trial.
Under the agreement, Rentschler Biopharma will be responsible for downstream processing to provide 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 aiming to ensure the safety and tolerability of a vaccine for use in humans, while maximising the mRNA harvested from the initial production process. Rentschler Biopharma will carry out this process at its headquarters in Laupheim, Germany.
Dr Frank Mathias, CEO of Rentschler Biopharma, said: “We are honored to contribute to BioNTech’s ‘Project Lightspeed’ and their work in developing this highly innovative mRNA vaccine. To tackle the COVID-19 pandemic, it is critical to bring high-quality, safe and effective vaccines to the public quickly and on a large scale. At Rentschler Biopharma, we feel it is important to do our part in combatting this virus. As a cGMP service provider with more than 40 years of proven manufacturing expertise, we are well suited to work with BioNTech to make their ground-breaking science a medical reality and will work tirelessly to this end.”
Federico Pollano, SVP Global Business Development of Rentschler Biopharma, added: “We are excited to have the opportunity to work with BioNTech on this urgent project, as well as over the long term. A critical success factor in all the projects we take on at Rentschler Biopharma is close collaboration with our clients. Working in partnership with BioNTech, we determined that the best way to address their COVID-19 vaccine drug substance manufacturing needs was to establish a dedicated mRNA production suite for them in our Laupheim facility.”