Rentschler Biopharma has agreed to serve as CDMO’s spouse for BioNTech, where Rentschler Biopharma will be for the key facets of BNT162b2 cGMP drug production, the mRNA-based SRAS-CoV-2 vaccine developed through Pfizer and BioNTech, and is recently in a global phase III clinical trial.
Rentschler Biopharma will take care of the subsequent remedy to deliver a purified drug. Impurities from the process and product will be removed from the intermediate group, which in the past was derived from mRN synthesis. This is a vital step in ensuring protection. and the tolerability of a vaccine for use in humans, while maximizing the amount of mRNA collected in the initial production process, according to Rentschler officials who will produce a purified drug substance at their headquarters in Laupheim, Germany.
“We are revered for giving a contribution to BioNTech’s Lightspeed Project and its paintings on this cutting-edge mNR vaccine,” said Frank Mathias, CEO of Rentschler Biopharma. “To combat the COVID-19 pandemic, it is imperative to provide high-quality, safe and effective vaccines to the public on a temporary and large scale. At Rentschler Biopharma, it is vital to make our component in the fight against this virus. As a cGMP service provider with over 40 years of proven production experience, we are well placed to work with BioNTech to make your innovative science a medical truth and will work tirelessly to do so.
BioNTech and Rentschler Biopharma say they will use a business style that adapts well to new technologies that urgently desire it and allows maximum flexibility to meet BioNTech’s progression and production requirements. In addition to the large-scale production of the COVID-19 vaccine, the agreement also supplies for the manufacture of small batches of other BioNTech RNA systems for use in clinical trials.
“We are very happy to have the opportunity to paint with BioNTech on this urgent as well as long-term project. “Added. Federico Pollano, Senior Vice President of Global Business Development at Rentschler Biopharma. La close collaboration with our clients is a good fortune in all the projects we adopt at Rentschler Biopharma. In partnership with BioNTech, we have created our thinking that the most productive way to satisfy your desires for vaccine drug production for COVID-19 is to identify an mRN production suite committed to them at our Laupheim facilities. This technique ensures that the capacity, the body of painters and the devices are in an appropriate position on the occasion. uninterrupted need for other ongoing projects on our site. It is also a technique that is temporary and easily scalable to meet long-term demands.