Joining Forces Against SARS-COV-2: Rentschler Biopharma Contributes to the Manufacturing of COVID-19 mRNA Vaccine

Published : 15 Oct 2020

Drug Name: BNT-162b2

Rentschler Biopharma SE, a number one world contract development and producing organization (CDMO) for biopharmaceuticals, proclaimed Associate in Nursing agreement to function as a CDMO partner for BioNTech. As Associate in Nursing's initial project, Rentschler Biopharma is going to be to blame for key aspects of cGMP (current smart producing practice) drug substance producing of BNT162b2, the mRNA-based vaccinum against SARS-CoV-2 that's being developed by Pfizer and BioNTech and is present during a world part three test.

Under the agreement, Rentschler Biopharma is going to be to blame for the downstream process to produce an extremely refined drug substance. method and product-related impurities are going to be effectively aloof from the intermediate pool, which has been antecedently derived from informational RNA synthesis. this can be a crucial step in making certain the security and tolerability of a vaccinum to be used in humans, whereas at an equivalent time increasing the number of informational RNA harvested from the initial production method. Rentschler Biopharma can turn out a refined drug substance at its headquarters in Laupheim, Germany.

Dr. Frank jock, chief executive officer of Rentschler Biopharma, said: "We square measure honored to contribute to BioNTech's 'Project Lightspeed' and they add developing this extremely innovative informational RNA vaccinum. To tackle the COVID-19 pandemic, it's essential to bring high-quality, safe, and effective vaccines to the general public quickly and on an oversized scale. At Rentschler Biopharma, we tend to feel it's vital to try to our half in combatting this virus. As a cGMP service supplier with quite forty years of tested producing experience, we tend to square measure well matched to figure with BioNTech to create their ground-breaking science a medical reality and can work inexhaustibly to the current finish."

BioNTech Associate in Nursingd Rentschler Biopharma can use an innovative business model that's well matched for a unique, desperately required technologies and permits the most flexibility to handle BioNTech's development and producing needs. additionally to large-scale production services for the COVID-19 vaccinum, the agreement additionally provides for small-batch production of BioNTech's alternative ribonucleic acid programs to be used in clinical trials.

Federico Pollano, SVP world Business Development of Rentschler Biopharma, added: "We square measure excited to possess the chance to figure with BioNTech on this imperative project, also as over the long run. An essential success considers all the comes we tend to attack at Rentschler Biopharma is shut collaboration with our purchasers. operating in partnership with BioNTech, we tend to determined that the simplest thanks to addressing their COVID-19 vaccinum drug substance producing wants was to determine an infatuated informational RNA production suite for them in our Laupheim facility. This approach ensures capability, staff, and instrumentation square measure prepared once required while not interruption of alternative in progress comes at our website. it's additionally Associate in the Nursing approach that's quickly and simply scalable to satisfy future demands."

Source: GlobalData.com