Pfizer Inc. (NYSE:PFE) and BioNtech (NASDAQ:BNTX) have partnered with Germany contract development band manufacturing organization, Rentschler Biopharma. The partnership is for the purification process of their mRNA-based SARS-CoV-2 vaccine, BMNT1762b2.
Rentschler to purify Pfizer and BioNtech’s COVID-19 vaccine drug substance
The companies are conducting late-stage clinical studies of the vaccine and expect to release data by next month. However, with logistical challenges dogging the partners’ prospects, they are turning to Rentschler to help in lightening the load of downstream purification. As per the terms of the agreement, Rentschler will purify the drug substance at its Lauphiem headquarters in Germany to provide a product which the companies will add to the medium and later bottle.
The purification will help ensure the safety of the vaccine and also ensures that a high viable mRNA volume of harvest. The agreement will also help in small-batch manufacturing of BioNtech’s RNA programs to be used in clinical studies. Federico Pollano, the SVP global business development at Rentschler Biopharma, said they are delighted to work with BioNtech on such an urgent project. He added that through the partnership, they established that the best way by having an mRNA production suite for purification of the drug substance at the Laupheim facility.
Pfizer and BioNtech face logistic challenges for the COVID-19 vaccine
BioNtech and Pfizer’s mRNA-based COVID-19 vaccine is a front runner in the races towards having a coronavirus vaccine. The companies are currently conducting phase 3 human trials, and they expect a readout early next month. Even though BNT162b2 will receive regulatory approval, the companies will face logistical challenges for global rollout, something their competitors don’t face.
There have been concerns about the temperatures required in storing mRNA vaccines, such as the one Pfizer and BioNtech are producing and the one from Moderna (NASDAQ:MRNA). This has been a limiting factor to distributors’ ability to ship the vaccines to clinics and the ability to deliver to a larger patient population. There are doubts from various experts about Pfizer and BioNtech’s plans to roll out the vaccine because of limiting storage needs.