• Rentschler Biopharma to provide cGMP manufacturing services for mRNA-based vaccine candidate, developed by BioNTech and Pfizer against SARS-CoV-2
• Commercial production will be conducted in Laupheim, Germany
• Rentschler Biopharma's innovative and highly flexible business model enables fast, high-quality, large-scale manufacturing for commercial supply as well as small batch production for clinical trials for other BioNTech RNA product candidates

LAUPHEIM, GERMANY and MILFORD, MA, USA - EQS Newswire- 8 October 2020 - RentschlerBiopharma SE, a leading global contract development and manufacturingorganization (CDMO) for biopharmaceuticals, today announced an agreement toserve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharmawill be responsible for key aspects of cGMP (current goodmanufacturing practice) drug substance manufacturing of BNT162b2, themRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer andBioNTech, and is currently in a global Phase 3 clinical trial.

Under the agreement, Rentschler Biopharma willbe responsible for downstream processing to provide highlypurified drug substance. Process and product-related impurities will beeffectively removed from the intermediate pool, which has been previouslyderived from mRNA synthesis. This is an important step in ensuring the safetyand tolerability of a vaccine for use in humans, while at the same timemaximizing the amount of mRNA harvested from the initial production process.Rentschler Biopharma will produce purified drug substance at its headquartersin Laupheim, Germany.

Dr. Frank Mathias, CEO of Rentschler Biopharma,said: "We are honored to contribute to BioNTech's 'Project Lightspeed' andtheir work in developing this highly innovative mRNA vaccine. To tackle theCOVID-19 pandemic, it is critical to bring high-quality, safe and effectivevaccines to the public quickly and on a large scale. At Rentschler Biopharma,we feel it is important to do our part in combatting this virus. As a cGMPservice provider with more than 40 years of proven manufacturing expertise, weare well suited to work with BioNTech to make their ground-breaking science amedical reality and will work tirelessly to this end."

BioNTech and Rentschler Biopharma will use aninnovative business model that is well suited for novel, urgently neededtechnologies and allows maximum flexibility to address BioNTech's developmentand manufacturing requirements. In addition to large-scale production servicesfor the COVID-19 vaccine, the agreement also provides for small-batchmanufacturing of BioNTech's other RNA programs for use in clinical trials.

Federico Pollano, SVP Global BusinessDevelopment of Rentschler Biopharma, added: "We are excited tohave the opportunity to work with BioNTech on this urgent project, as well asover the long term. A critical success factor in all the projects we take on atRentschler Biopharma is close collaboration with our clients. Working inpartnership with BioNTech, we determined that the best way to address theirCOVID-19 vaccine drug substance manufacturing needs was to establish adedicated mRNA production suite for them in our Laupheim facility. Thisapproach ensures capacity, staff and equipment are ready when needed withoutinterruption of other ongoing projects at our site. It is also an approach thatis quickly and easily scalable to meet future demands."

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contractdevelopment and manufacturing organization (CDMO), focused exclusively onclient projects. From its headquarters in Laupheim, Germany and its site inMilford, MA, USA, Rentschler Biopharma offers process development andmanufacturing of biopharmaceuticals as well as related consulting activities,including project management and regulatory support. Rentschler Biopharma'shigh quality is proven by its long-standing experience and excellence as asolution partner for its clients. A high-level quality management system, awell-established operational excellence philosophy and advanced technologiesensure product quality and productivity at each development and manufacturingstep. In order to offer best-in-class formulation development along thebiopharmaceutical value chain, the company has entered into a strategic alliancewith Leukocare AG. Rentschler Biopharma is a family-owned company with about1,000 employees. For further information, please visit www.rentschler-biopharma.com. Follow RentschlerBiopharma on 

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