- 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
USA – EQS Newswire – 8 October 2020 – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced an agreement to serve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP (current good manufacturing practice) drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, and is currently in a global Phase 3 clinical trial.
Under the agreement, Rentschler Biopharma will be responsible for downstream processing to provide highly purified drug substance. Process and product-related impurities will be effectively removed from the intermediate pool, which has been previously derived from mRNA synthesis. This is an important step in ensuring the safety and tolerability of a vaccine for use in humans, while at the same time maximizing the amount of mRNA harvested from the initial production process. Rentschler Biopharma will produce purified drug substance at its headquarters in Laupheim, Germany.
Dr. Frank Mathias, CEO of Rentschler Biopharma, 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. At Rentschler Biopharma, we feel it is important to do our part in combatting this virus. As a cGMP service provider with more than 40 years of proven manufacturing expertise, we are well suited to work with BioNTech to make their ground-breaking science a medical reality and will work tirelessly to this end.”
BioNTech and Rentschler Biopharma will use 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.
Federico Pollano, SVP Global Business Development of Rentschler Biopharma, added: “We are excited to have the opportunity to work with BioNTech on this urgent project, as well as over the long term. A critical success factor in all the projects we take on at Rentschler Biopharma is close collaboration with our clients. Working in partnership with BioNTech, we determined that the best way to address their COVID-19 vaccine drug substance manufacturing needs was to establish a dedicated mRNA production suite for them in our Laupheim facility. This approach ensures capacity, staff and equipment are ready when needed without interruption of other ongoing projects at our site. It is also an approach that is quickly and easily scalable to meet future demands.”
About Rentschler Biopharma SE
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients.
A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with about 1,000 employees.