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Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.
Rentschler Biopharma, a global contract development and manufacturing organization (CDMO), announced on Oct. 8, 2020 that it is entering into a partnership with BioNTech for the drug substance manufacturing of BNT162b2, an mRNA-based COVID-19 vaccine being developed by Pfizer and BioNTech.
Under the terms of the agreement, Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany, a Rentschler press release said. Additionally, the agreement will address small-batch manufacturing of BioNTech's other RNA programs for use in clinical trials.
"We are honored to contribute to BioNTech's 'Project Lightspeed' and their work in developing this highly innovative mRNA vaccine,” said Dr. Frank Mathias, CEO of Rentschler Biopharma, in the press release. “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."
"We are excited to have the opportunity to work with BioNTech on this urgent project, as well as over the long term,” added Federico Pollano, senior vice-president, global business development, Rentschler Biopharma, in the press release. “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. This approach ensures capacity, staff, and equipment are ready when needed without interruption of other ongoing projects at our site. It is also an approach that is quickly and easily scalable to meet future demands."