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.
In vitro biochemical assays make the high throughput screening of large compound libraries possible – but without a strong hit-to-lead process, time and money are often wasted seeking out the most promising starting points. Join us to learn best practices for triaging hits & focusing efforts.
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.
But even with regulatory approval, the partners’ global rollout could be hindered by logistical issues that its competitors simply don’t face.
In August, experts expressed concern that the temperatures required to store mRNA vaccines—both Pfizer and BioNTech’s as well as Moderna’s—were “severely limiting” to distributors’ ability to ship the shots and to clinics’ ability to administer them to a wide swath of patients.
Experts specifically cast doubt on Pfizer and BioNTech’s rollout plans given the stringent cold-storage needs for their candidate, which must be kept at a frigid -94° Fahrenheit (-70° Celsius), and will last for only 24 hours at refrigerated temps between 35.6°F and 46.4°F (2°-8°C).
Even still, Pfizer and BioNTech have moved forward with plans to produce billions of doses of the vaccine each year, aided by the recent pickup of a Novartis manufacturing site.
Last month, BioNTech agreed to buy a Novartis biologics facility in Marburg, Germany, that is expected to be fully operational in the first half of 2021. The site could have an annual capacity of up to 750 million doses of BNT162 when fully operational, BioNTech said.