Leveraging biologics capacities that were expanded at its Laupheim, Germany, site in 2015 and 2016, Rentschler will be responsible for key aspects of cGMPdrug substance manufacturing of BNT162b2, the mRNA-based vaccine against Covid-19 being developed by Pfizer and BioNTech and currently in a global Phase 3 clinical trial.

A significant part of, Rentschler's task will be to remove impurities from the vaccine candidate’s  manufactured mRNA in order to ensure the highest amount of viable mRNA is harvested and the safety of the finished vaccine.

BioNTech and Rentschler will use a business model that Federico Pollano, SVP global business development at Rentschler Biopharma, said is well suited for novel, urgently needed, technologies and allows maximum flexibility to address BioNTech's development and manufacturing requirements.

The companies, Pollano said, determined that the best way to address the vaccine developers’ drug substance manufacturing needs was to establish a dedicated mRNA production suite at Rentschler’s Laupheim site. This approach, he said, ensures that capacity, staff and equipment are ready when needed, without interruption of other ongoing projects at the site. Moreover, “it is as quickly and easily scalable to meet future demands.”

The Pfizer and BioNTech mRNA-based vaccine candidate from BioNTech’s from its BNT162 program considered most promising has emerged as one of the frontrunners in the race to find a method of achieving immunity to the novel coronavirus.

The American-German partnership is preparing to present data from its Phase 3 trials, possibly next month. A rolling application has already been submitted to the European Medicines Agency, and the approval process with the US Food and Drug Administration (FDA) is expected to begin soon. In the background, however, unexpected hurdles have popped up.

US biotech sues BioNTech-Pfizer and Regeneron

Allele Biotechnology and Pharmaceuticals, a San Diego, California-based US firm specializing in technology for clinical and therapeutic use, has filed suit against the vaccine partners, alleging that BNT162 violates its mNeonGreen fluorescent protein patent. As compensation, it is demanding damages that amount “no less than a reasonable royalty.”

The San Diego firm is also suing Regeneron, claiming that this company, too, infringed the mNeonGreen patent. It points to several academic papers published in the magazine Science and co-authored by Regeneron employees that it claims include information on how antibodies against Covid-19’s s spike protein were tested with the fluorescent protein.

In its complaint, Allele said mNeonGreen “is one of the brightest and most stable monomeric fluorescent proteins to date, and therefore allows for rapid detection of molecular changes to determine the cells’ response to treatments.

“Hundreds of organizations and universities have active licenses to use Allele’s mNeonGreen technology,” founder and CEO, Jiwu Wang said. “Our goal is to have these companies recognize, as many others have before them, the hard work that went in to developing this technology and to respect our intellectual property."

Regeneron told US media it disagrees with Allele’s claims and that it will “vigorously defend” its position. Pfizer and BioNTech have not publicly responded to the complaint.

Author: Dede Williams, Freelance Journalist