Pfizer, BioNTech bring on Germany’s Rentschler for purification of mRNA-based coronavirus shot – FiercePharma

Pfizer and BioNTech are in the home stretch for a late-stage clinical trial of their mRNA-based COVID-19 vaccine, with data expected next month. But as logistical challenges dog the partners’ prospects, a German manufacturer is jumping on board to help lighten the load.

Pfizer and BioNTech have reached a deal with German contract manufacturer Rentschler Biopharma to handle the downstream purification process for the pair’s mRNA-based COVID-19 vaccine, the companies said Thursday.

Rentschler’s work at its Laupheim, Germany facility will be to remove impurities from Pfizer and BioNTech’s manufactured mRNA, leaving the purified drug substance that is later added to medium and bottled, the CDMO said. This process helps ensure the safety of the finished vaccine, according to Rentschler, and ensures the highest amount of viable mRNA is harvested. 

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On top of its COVID-19 work, Rentschler will also handle “small-batch” manufacturing for a range of BioNTech’s other mRNA clinical-stage projects, Rentschler said. 

Pfizer and BioNTech’s mRNA-based vaccine from its BNT162 program has emerged as a frontrunner in the race for a COVID-19 vaccine with phase 3 human trials currently ongoing and a readout expected as early as November. 

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Author: The Covid-19 Channel