December 9, 2020 PAP-Q4-20-CL-028
The continuous optimization of operational fitness has always been an integral part of our strategy. In alignment with local health authorities and with the help of an internal business continuity plan, we adopted comprehensive company-wide measures for the changing situation and successfully secured ongoing operations and supply continuity.
Across the industry, the COVID-19 pandemic has underlined the importance of the digital landscape and the need to stay connected and access critical information in real time. At Rentschler Biopharma, we saw an opportunity to enhance our digital infrastructure to move further toward digital meetings and paperless documentation and extended this approach to digitally integrate all departments using central storage and synchronization.
As a company that always strives to assess and reinvent ourselves, the pandemic drove us to evaluate operations through three lenses: resilience, reformation, and reimagination. We had launched an initiative to strengthen our resilience within the framework of Strategy 2025 before the COVID-19 outbreak. This held us in good stead in overcoming disruptions in global supply chains for raw materials — a major challenge during the pandemic — by establishing alternative sources and balancing global and local vendors. To address reformation, we assessed our core business processes to find ways to increase their sustainability and efficiency, importantly including our strategies to acquire and retain talent. Reimagination involved reflecting on the full picture of how we work internally and in collaboration with our clients to find ways to unleash the full potential of those interactions. This is notably done through the “Rentschler New Work” initiative, which is focused on interactive leadership training across our organization, addressing diverse topics, including the new economy, business model generation, and employer branding.
At Rentschler Biopharma, we are invested in our clients’ success. Projects targeting COVID-19 have been given priority, enabling the rapid establishment and short-term provision of process development and manufacturing capacity for the production of drugs that can tackle the pandemic.
We recently announced an agreement to serve as CDMO partner for a COVID-19 mRNA vaccine program with BioNTech, a German biotech innovator focused on immunotherapies. Rentschler Biopharma is providing cGMP drug substance manufacturing of BNT162b2, an mRNA-based vaccine developed against SARS-CoV-2. The vaccine was developed jointly by BioNTech and Pfizer and has been submitted to the European Medicines Agency for a rolling review.
Unlike traditional vaccines, mRNA vaccines introduce mRNA encoding viral proteins, which function as a template to allow the patient’s cells to produce the infectious protein to induce an immune response against the viral antigen with no risk of assembly of functional viral particles. Evidence suggests that mRNA vaccines may be more potent and straightforward to manufacture than traditional vaccines and may be easier to scale up to the level needed for true global vaccination efforts.
For a COVID-19 vaccine planned for administration on a global scale, it is critical to provide a highly purified drug substance to ensure its safety and tolerability in patients. The mRNA for the vaccine is produced by BioNTech in bioreactors using a cell-free process. Rentschler Biopharma will provide downstream processes to effectively remove process- and product-related impurities. Optimized downstream processes can also maximize the amount of mRNA that can be harvested by the upstream processes, increasing output and efficiency.
To best support the range and scale of services needed for the COVID-19 vaccine program on an accelerated timeline, we have established a dedicated mRNA production suite in the Laupheim facility to ensure that the needed capacity, equipment, and staff are available to work on the program without conflict.
The partnership leverages a unique business model that creates maximal flexibility to address the scope of BioNTech’s development and manufacturing requirements for a COVID-19 vaccine. Beyond the large-scale purification services for the mRNA vaccine BNT162b2, Rentschler Biopharma can also perform development and manufacturing for other BioNTech RNA programs for use in clinical trials, as needed.
Through this and other programs, we are navigating the pandemic by seizing the opportunity to innovate, finding novel ways to work and communicate more dynamically throughout our operations and in our partnerships. By finding new synergies and efficiencies, we create sustainable value for our client partners while helping to tackle the COVID-19 pandemic.
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Rentschler Biopharma SE, located in Laupheim, Germany, is a leading contract development and manufacturing organization (CDMO), focused exclusively on clients' projects. Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. The company's clients include innovative biotech companies and major pharmaceutical companies around the world. 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.