Rentschler Biopharma SE Sets Foot in the U.S. to Strengthen its World-Class CDMO Position

The biopharmaceutical industry is undergoing significant change. To remain successful in an evolving marketplace, a biopharmaceutical contract development and manufacturing organization (CDMO) must think strategically and anticipate future client demands to determine how to best provide the novel technologies and regional capabilities that will be required going forward. With the purchase of a brand new facility in the United States, Rentschler Biopharma SE has taken another step on its path toward the future.

Putting Current Trends in Context: Our Strategy 2025 Initiative

Given the rapid development of next-generation therapies and new manufacturing paradigms for biologic drug production, it is essential that CDMOs supporting the biopharmaceutical industry continuously evolve. As an established technology leader, Rentschler Biopharma is pursuing a proactive and forward-thinking approach to providing solutions — embodied in our Strategy 2025 initiative — to ensure that we continue to be a partner of choice for our clients.

Intensive evaluation of key trends in the biopharmaceutical industry has helped us to gain greater insight into the key factors driving the selection of contract service providers: quality, close collaboration in strategic partnerships and transparent communication. Clients want to be partners with CDMOs that can provide support throughout the development and commercialization process — from gene to vial and from concept to market.

In order to ensure growth and sustainability, we will focus on three strategic dimensions: geography, clients and innovation. Our Strategy 2025 initiative — with options for new technologies and business models — guarantees Rentschler Biopharma’s role as a technology leader with a focus on novel biomolecules and bioprocessing approaches that are designed to increase efficiency and productivity. This addresses all aspects of our development and manufacturing activities, from our platform technologies to how our operations will be managed and how our people will work over the coming decade.

Our existing strategic partnerships with Leukocare AG and Rentschler Fill Solutions GmbH will also benefit from Strategy 2025, as we strive to broaden our value chain and increase the services we can provide to our clients: Leukocare AG contributes its best-in-class formulation development and Rentschler Fill Solutions GmbH provides their state-of-the-art fill and finish services. These collaborations allow us to offer a one-stop-shop option. 

With our new production site, we are able to answer our U.S. clients’ strong requests to bring our innovation and technology to their doorstep, underscoring our deep commitment to meeting their unique market needs.

The acquisition of the facility answers our U.S. clients’ strong request to bring our innovation and technology to their doorstep and underscores our deep commitment to meeting their unique market needs.

Global Reach: Improving Proximity For Clients

Our first foothold in the United States was established through the acquisition of a manufacturing facility from an affiliate of Shire plc. The Milford site, with its 93,000-ft² footprint, provides both expanded capacity and a greater degree of flexibility to better position Rentschler Biopharma and, therefore, our clients. There is also plenty of room for further expansion of capacity and capabilities. The site is a modern facility with state-of-the-art technologies. 

All of the approximately 70 employees at the Milford site have chosen to continue employment under Rentschler Biopharma. We are excited to welcome the highly qualified, intelligent and experienced staff at the Milford site to the Rentschler family. We have initiated a close and intensive communication and collaboration between the sites and, ultimately, begun to implement joint administration, quality, technical operations and other systems across both sites. We will continue to manufacture a key product from the Shire portfolio and are planning to expand into a multiproduct site in the near future. Together with the existing leadership team, we have set things in motion to integrate Milford into the Rentschler family and together take the next step into our future. As a family-owned business, this is a high priority for us. 

The site’s location in an important and established biotechnology hub gives us access to the outstanding talent pool and numerous novel technologies being developed in the area, which will facilitate our plans for expansion and better position us to support our evolving clients’ needs.

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Our History — Our Future

Rentschler Biopharma is one of the most experienced biologics firms in the world. Our company was founded in 1927 as a privately held pharmaceutical company, and we entered the biologics space in 1974. Since then, we have been a pioneer in working with recombinant cell lines and single-use technologies at commercial scale. We have extensive experience in the production of a wide range of biomolecules, from monoclonal and bispecific antibodies to fusion proteins, recombinant enzymes, blood factors, cytokines and growth factors. 

The company became a fully dedicated CDMO in 1997, and today we pursue a bioprocessing approach that relies on bioinformatics, advanced modeling tools and lab-scale analytics to enable the development of optimized, robust, reproducible and scalable cGMP-ready bioprocesses that reduce costs, time and effort.

Our more than 40-year track record allows us to guide our clients with consultation in all matters related to phase I/II development up to market launch. Our experts in project management and regulatory affairs support our clients throughout the entire value chain of their products. In the future, we plan to offer more flexible business models to our clients and to adapt to their specific needs on the level of a closer and more detailed partnership. This will accelerate their path to clinic and market.

With access to development and manufacturing facilities in both Europe and the United States, we will continue to build our capacities in advanced technologies that facilitate the robust, scalable production of complex biomolecules.

Fully Dedicated to our Clients

Rentschler Biopharma is one of the global leaders focused on mammalian cell culture. We have worked with over 130 clients and 260 molecules in the last few years alone. Despite this leadership position, we remain a medium-sized, family-owned company with a 100% focus on our clients’ projects. As a fully dedicated CDMO, our clients have no concerns that their projects might compete with any internal development efforts.

At Rentschler Biopharma, our goal is to establish partnerships with our clients to enable us to act as an extension of their workbench. Our flexibility in providing tailored services that meet the specific needs of each project and client adds further value. As a solution provider, we focus on understanding project objectives and the challenges our clients face in their biologic bioprocess, formulation and analytical development and optimization efforts. With capabilities ranging from cell line development through fill/finish and global regulatory support, our clients can rapidly achieve cGMP production of both clinical and commercial quantities. The Milford site acquisition greatly amplifies our ability to offer our U.S. clients the very best of our innovative solutions, technological advancements and expertise moving forward. 

Federico Pollano

Federico Pollano is Senior Vice President at Rentschler Biopharma, located in Laupheim, Germany. He has almost 30 years of experience in pharmaceuticals and biopharmaceuticals, mainly in senior and executive positions, at the following companies; Polpharma Biologics, Richter-Helm BioTec, Helm, BioGenerix, Glaxo Wellcome and Zambon. Pollano studied biology at Bielefeld University, Germany, and at the German Primate Center, Göttingen.