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Life Sciences Focus: Biologics Rentschler Biopharma: biopharma CDMO


supports drug and vaccine development Germany-headquartered biologics CDMO Rentschler Biopharma has established a number of new collaborations this year, including one to support the development of a COVID-19 vaccine.


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eadquartered in Germany, Rentschler Biopharma SE has become established as a leading global CDMO for biopharmaceuticals and vaccines and has now entered the race to develop a vaccine against the SARS-CoV-2 (COVID-19) virus by agreeing to serve as the CDMO partner for BioNTech. As an initial project, Rentschler will be responsible for key aspects of cGMP drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech and which 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


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


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.”


Innovative business model


in Laupheim, Germany. Dr. Frank Mathias, CEO of Rentschler Biopharma, comments: “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,


BioNTech and Rentschler Biopharma will use an innovative business model that is well suited for novel, urgently needed technologies and that 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 programmes for use in clinical trials.


Federico Pollano, SVP Global Business Development of Rentschler Biopharma, adds: “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.”


Tackling drug development complexity


In a separate development, in July of this year Rentschler Biopharma teamed up with Vetter in a collaboration aimed at simplifying manufacturing processes and optimizing time- to-market. Vetter and Rentschler established the collaboration to enhance their services and offer complementary skills and experience to customers along the biopharmaceutical value chain. The compnies said that with drug development growing increasingly complex and cost- intensive, biopharmaceutical companies are under significant pressure to streamline their products’ path to market and that the goal of the collaboration is to create long-term value through the alignment of manufacturing approaches that enable clients to bring their products to patients


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more easily and faster. “Like us, Vetter is a family-run and well-established service provider. We have known each other for many years and share a commitment to high quality standards and sustainable value creation and our strategic collaboration is aimed at reducing complexity for our clients, with the joint overarching goal of bringing promising new therapies to patients with serious and rare diseases faster than before,” states Prof. Dr. Nikolaus F. Rentschler, Chairman of the Board of Rentschler Biopharma. Senator h.c. Udo J. Vetter, Chairman of the Advisory Board of Vetter, adds: “It is important for businesses to sometimes think outside the box. Pursuing future- oriented and innovative ideas is part of both of our companies’ DNA. The alignment of Rentschler Biopharma’s experience in drug substance manufacturing and our own core competency in drug product pharmaceutical manufacturing is yet another opportunity to pursue.”


Combining


biopharmaceutical manufacture and product finishing


The alliance of the two leading CDMOs will leverage Rentschler Biopharma’s extensive experience in drug substance manufacturing, including bioprocess development and API production, and Vetter’s expertise in aseptic fill and finish and secondary packaging. The companies have already identified


opportunities where early and active exchange of know-how and best-practice will benefit both clients of the two companies and their drug products. In the coming months, these opportunities will be further validated in pilot client projects with joint teams from both companies. Rentschler and Vetter said they will continue to independently address and service current and new clients as they explore opportunities for cooperative integration of approaches to complex molecules in the rapidly evolving global health care environment.


Extended collaboration with Genmab In another example of


technological cooperation in the biopharmaceutical field, in May of this year Rentschler entered into a strategic collaboration with US company Genmab for the process development and manufacture of bispecific antibodies generated with Genmab’s DuoBody technology platform. The partnership uses an innovative business model which, the companies say, fits well with the expansion plans for Rentschler Biopharma’s US site in Milford, Massachusetts.


Pollano commented: “The work we will do for Genmab at our US site represents a first-of-its-kind collaboration that will involve several novel projects and enable the client to decide in a flexible and agile way which projects to advance and when.”


Life Sciences Focus: Biologics


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


Rentschler acquired its US site in the greater Boston area in January 2019. Holding FDA, EMA and Health Canada licences, the 93,000 square foot facility will be qualified as a multi- product site offering clients innovative solutions. The first step in expanding Rentschler Biopharma’s Center of Excellence in North America is a 500 L single-use bioreactor while the next steps include another building for large-scale single-use manufacturing and lab capacity


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for new therapeutic modalities. The company plans to leverage its expertise for client projects through every phase, be it early- stage development or clinical and commercial production, and with its innovative and highly flexible business model, the Milford site is already taking on new projects, including complex and difficult-to-manufacture proteins. In total, Rentschler Biopharma intends to continuously invest in these expansions and to hire up to 75 additional people at the site to keep pace with the site development and business growth. “We are grateful for the trust that Genmab has put in us based on our work for them at our Laupheim site. This extended collaboration with Genmab at our US innovation hub is a perfect fit with our expansion. Our growth will enable us to support our partner at each step of the way as their plans advance and evolve,” says Mathias. “Since acquiring the US site in 2019, we have accomplished a lot and are very pleased our expansion is moving forward as planned and on time. We look forward to bringing in additional innovative projects from both new and existing clients.”


Further information Rentschler Biopharma SE Ph: +49 7392 701 0 E: info@rentschler- biopharma.com W: www.rentschler- biopharma.com


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