Rentschler Biopharma brought in to help manufacture Pfizer and BioNTech COVID-19 vaccine

8 October 2020

German contract development and manufacturing organization (CDMO), Rentschler Biopharma, is to provide cGMP manufacturing services for the mRNA-based vaccine candidate being developed by BioNTech (Nasdaq: BNTX) and Pfizer (NYSE: PFE) against SARS-CoV-2.

BNT162b2 is currently in a global Phase III clinical trial and is one of the leading candidates in the race to become the first COVID-19 vaccine to gain approval in the western world.

Under the agreement, Rentschler 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.

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