German contract research specialist key to making COVID vaccine
Rentschler Biopharma, a leading German contract development and manufacturing organization (CDMO), is playing a vital role in making the BioNTech and Pfizer's vaccine for COVID-19, BNT162b2. The Laupheim-based company has been responsible for essential purification of the products of mRNA synthesis.
Rentschler contracted in October to carry out downstream processing of mRNA according to cGMP (current good manufacturing practice). The company says it is removing process and product related impurities from the intermediate pool resulting from mRNA synthesis. Rentschler adds this important step ensures the safety and tolerability of a vaccine for use in humans, while maximizing the mRNA from the initial production process. The work is being done at Rentschler headquarters in Laupheim, Germany, although the company also has a site in Milford, Massachusetts in the US.
At the time the production agreement was announced, Rentschler Biopharma's CEO, Dr. Frank Mathias said. "We are honored to contribute to BioNTech's 'Project Lightspeed' and their work in developing this highly innovative mRNA vaccine. To tackle the COVID-19 pandemic, it is critical to bring high-quality, safe, and effective vaccines to the public quickly and on a large scale." He added that the company has 40 years of proven expertise.
The cooperation between BioNTech and Rentschler is characteristic of Germany's medical biotechnology sector, which has demonstrated strength and expertise in contract research. According to Rentschler, the partners are using an innovative business model that is well suited for novel, urgently needed technologies and allows maximum flexibility to address BioNTech's development and manufacturing requirements. In addition to large-scale production services for the COVID-19 vaccine, the agreement also provides for small-batch manufacturing of BioNTech's other RNA programs for use in clinical trials.
The export initiative for the German healthcare industry, HEALTH MADE IN GERMANY, is the place to learn more about how Germany's medical biotechnology sector works. It has produced a video on the sector called MEDICAL BIOTECHNOLOGY MADE IN GERMANY, featuring experts like Rentschler CEO Frank Mathias. They tell viewers firsthand why the sector is so strong globally. Additionally, the initiative has an online directory of German healthcare companies and the Company Directory: Contract Research Organizations that are available on its website.