December 9, 2020 PAP-Q4-20-CL-023
With the biopharmaceutical industry undergoing significant transformation, it is essential that CDMOs evolve to meet the intricate, dynamic needs of their clients. As a family-owned business backed by strong partnerships — with an outlook toward the future and a commitment to continue to build sustainably — Rentschler Biopharma has gleaned external insights into trends and challenges in the biopharmaceutical industry that will guide how the organization operates over the long term. The company is focusing on expanding services and building up strategic alliances with technology leaders that provide complementary services to simplify the clients’ complex challenges with best-fit solutions. Reducing time to market with the highest quality services is the top priority — not only in the core business of bioprocess development and manufacturing, but in project management, regulatory support, and consulting. In addition to these alliances with technology providers, the company is building long-term partnerships with clients in order to function as an extension of their operations, thus providing more strategic and holistic support.
Rentschler Biopharma’s “Strategy 2025” adopts innovation, growth, and partnership to establish a formidable competitive advantage and create greater value for our clients in the future. The plan addresses all facets of our development and manufacturing activities — from the platform technologies we will need, to how our employees will work in the future, and how to continue to meet and exceed client expectations.
The inception of Strategy 2025 came in 2016, after I took on the role of CEO. It was important to develop a long-term vision for our organization to define what the company should look like in 2025, given the megatrends that will shape society, the industry, and the world. Over 18 months, we garnered insights and feedback from internal and external experts, including companies outside of the pharmaceutical industry, physicians from renowned hospitals, academia, patients, venture capitalists, recruiters, and — most importantly — our clients.
The heterogeneity of contributors created a vast data pool and a solid platform from which to determine the path the company should take moving forward. Our analysis has helped us make informed projections involving the treatment of patients with severe and rare diseases, the application of monoclonal antibodies (mAbs) as a therapy of choice, and the progression and importance of cell and gene therapies. Our findings highlighted the shift to personalized medicine, particularly in cell and gene therapies. Another impactful societal trend for the industry involves the aging global population, most of whom expect to stay active even after retirement. Younger people are also approaching healthcare differently and are focused on prevention; they expect to remain healthy well into the future.
Rentschler Biopharma recognizes the need to evolve to meet the changing demands of our clients, which is why we prioritize three pillars: improving conventional biopharmaceutical development and production processes, building on our existing capabilities for designer biomolecules, and meeting the needs for new therapeutic modalities. Our approach centers around improving processes to reduce time-to-clinic and time-to-market, including fit-for-purpose process solutions that not only improve efficiency and productivity but also enhance interactions with clients and partners to enable more participation in the development process. We develop standardized platform processes that are prevalidated and prequalified, offer a simpler, streamlined pathway, minimizing risk and reducing development timelines. Integrated design and development are combined with improved workflow strategies and approaches for reorganizing unit operations, including automation and process intensification.
We are committed to continuously developing methods that further enhance our proven capabilities to produce complex designer molecules. This includes the ability to produce customized expression hosts and supporting bioprocesses in optimized, integrated solutions for the efficient assembly and stabilization of biomolecules with complex architectures. Our smart bioprocessing approach enables the creation of optimized, robust, and replicable cGMP-ready bioprocesses from the start, reducing costs, time, and effort. Strategy 2025 also addresses innovative therapeutic technologies outside of mammalian cell culture, including viral vectors for the production of gene and cell therapies. We are broadening our already substantial knowledge of complex molecular entities into new biomolecules and modalities, as well as expanding into exciting new areas.
In addition to identifying ways to improve client interactions and innovate, planning for Strategy 2025 enabled us to identify opportunities for significant growth. When our North American clients expressed a desire for Rentschler Biopharma to establish a local site in the region, we took action. With about a third of our total revenue generated in the United States, we acquired a facility in Milford, Massachusetts, near the renowned Boston biotech hub. This expansion unlocked access to new technologies, a robust and diverse talent pool, and the opportunity to exchange ideas with leading industry and academic experts.
Strategy 2025 is also supported by our technology alliances with companies whose offerings integrate seamlessly into our business processes. These strategic alliances extend the exceptional level of services that we can offer while driving further innovation within the company. Our vision is to serve as a CDMO that can support our client–partners with services from gene to patient.
We will continue building strategic capacity to fulfill the demand for emerging, life-saving therapies and collaborating with our partners to develop mutually beneficial alliances that drive supply and delivery to patients with reduced time-to-market, the highest quality of biopharmaceuticals, and unrivaled efficiency — from mAbs to highly complex biomolecules and viral vectors. Strategy 2025 will ensure that our business models, services, and talent will continue to accelerate client projects from concept to market execution, cementing our reputation as a premium outsourcing partner translating fundamental research breakthroughs into effective treatments for patients.
Rentschler Biopharma’s “Strategy 2025” adopts innovation, growth, and partnership to establish a formidable competitive advantage and create greater value for our clients in the future.
We guarantee best-fit solutions for our clients’ products by balancing timeline requirements with a comprehensive manufacturability assessment, with quality always paramount. This commitment is reflected in our outstanding regulatory track record, as well as our exceptional client-oriented project management and regulatory support.
Rentschler Biopharma’s collaborative approach is strengthened by the foundational pillars of our core capabilities, including cell line development, process development, formulation development, analytical development, manufacturing, and project management.
Our expertise in cell line development includes the application of mammalian cell lines for the expression of recombinant proteins and the development of high-yield production cell lines. We also specialize in the development, optimization, and validation of cell culture and the purification of recombinant proteins, and we develop customized processes for active ingredients with efficient process transfer. Having expanded our formulation capabilities through our alliance with Leukocare AG, we offer improved stability of therapeutic proteins in dry and liquid formulations, including highly concentrated products. Our analytical methods ensure quality and purity according to all cGMP guidelines, and our testing services include identity, purity, and potency testing. Furthermore, our manufacturing capacities provide flexible multiproduct sites for upstream and downstream processes, with single-use (SU) bioreactors up to 2,000 L and stainless-steel bioreactors up to 3,000 L.
To create new efficiencies for our clients by linking complementary services across the value chain under an integrated offering, Rentschler Biopharma seeks strategic alliances with best-in-class providers. Their offerings are integrated seamlessly into our business processes, ensuring that all parts of the project are aligned. These strategic alliances and collaborations extend the high level of service that our CDMO offers while driving further innovation within the organization.
One such alliance is with Leukocare, the exclusive formulation developer for Rentschler Biopharma, which provides a bioinformatic, algorithm- and database-driven approach to drug product stabilization. Unlike conventional approaches, Leukocare’s technology explores a broader design space, which obviates the need for high-throughput screening while also increasing the probability of successful formulation. This alliance allows us to offer clients advanced formulation capabilities from concept to market and leverage Leukocare’s formulation technology at every relevant step of the development and manufacturing process. The technology improves the stability and quality of antibodies and other biopharmaceuticals — including vaccines, live viral vectors and protein components of biologically functionalized medical devices — at all concentrations in liquid and dry formulations. This is accomplished by increasing the thermal stability of biotherapeutics, preventing molecular degradation and potentially improving storage at room temperature, and by enabling lyophilization of drug products, which can reduce manufacturing costs and increase the convenience of administration while maintaining efficacy and activity.
To create new efficiencies for our clients by linking complementary services across the value chain under an integrated offering, Rentschler Biopharma seeks strategic alliances with best-in-class providers.
Another strategic collaboration enhances our services and offers complementary skills and experience along the biopharmaceutical value chain. On July 6, 2020, we announced a strategic collaboration with Vetter, another family-owned CDMO. This collaboration creates long-term value for our respective clients through the alignment of manufacturing approaches and holds great promise for further simplifying client solutions. By combining Vetter’s expertise in aseptic fill and finish and secondary packaging with our expertise in drug substance manufacturing, including bioprocess development and active pharmaceutical ingredient (API) production, there are numerous opportunities for both companies to share knowledge and best practices and gain market foresight. We see long-term potential in this partnership between two industry leaders, both of whom have a presence in Europe and the United States, as well as important synergies between our business portfolios. We are confident that combining our expertise will allow us to deliver new pathways for biopharmaceutical development and to address challenges facing the industry with our collective insight.
We have entered into a commercial licensing agreement with Horizon Discovery, a global leader in the application of gene editing and gene modulation for cell line engineering, whereby Horizon's CHOSOURCE™ platform would be used in combination with our novel in-house process for cell line development for difficult-to-express proteins. Horizon's gene-edited glutamine synthetase (GS) knockout Chinese hamster ovary (CHO) K1 cGMP-compliant cell line complements our existing service offering, providing a royalty-free, state-of-the-art alternative for the production of highly complex proteins.
Rentschler Biopharma's integrated platform process, together with Horizon's cell line, provides solutions that translate complex medical research into exceptional biopharmaceuticals, elevating the standard of protein expression and allowing clients access to a robust and flexible approach for designer protein therapeutics. Horizon’s portfolio of tools and services helps scientists gain a greater understanding of gene function, identify genetic drivers behind human disease, and deliver biotherapeutics, as well as cellular and gene therapies for precision medicine. In addition, diagnostic workflows can be developed and validated to enable almost any gene to be altered or its function modulated in human and other mammalian cell lines. This alliance embodies the Strategy 2025 spirit of providing wholly integrated solutions across the entire value chain, significantly broadening our fit-for-purpose approach and empowering organizations of all sizes to drive efficiencies in biotherapeutic manufacturing.
The same drive to provide integrated solutions to our clients led to the recent licensing agreement that we formed with ATUM, an industry leader in synthetic biology solutions. This agreement offers full access to ATUM’s proprietary Leap-In-Transposase® platform to enhance our ability to provide stable, high-titer manufacturing cell lines. The Leap-In-Transposase® platform combines proprietary algorithms and unique genetic vector elements to harness a mechanism based on transposons for efficient genomic insertion of genetic material — which is ideal for the development of recombinant antibodies, including complex, multi-chain proteins like bispecific monoclonal antibodies. In concert with the CHO GS KO platform licensed from Horizon, access to this technology will allow us to produce high-yielding cell lines under very rapid timelines, even for complex therapeutic proteins, creating a simple, integrated solution for these challenging programs.
We view our clients as partners and the best-in-class services that we provide as extensions of their operations.
Rentschler Biopharma maintains a focus on client needs across our operations. Naturally, our clients are seeking high quality and optimum solutions for all their biopharmaceutical programs. To these ends, we are continually adding capabilities to our service offering. We view our clients as partners and the best-in-class services that we provide as extensions of their operations. We truly understand drug development and all aspects of the product through its entire life cycle, as well as the challenges our clients face to get their therapies into the clinic and into the market as quickly as possible. Our client-oriented philosophy touches upon every aspect of how we do business — from project management through the establishment of strategic alliances to our robust record of quality excellence — keeping our clients and our company ahead of the curve in the rapidly changing biopharma landscape.
The strategic partnerships that we forge with clients offer a next level of support. As always, we provide these clients with our expertise, experience, and quality guarantee, but such longer-term partnerships allow us to focus on the client’s point of view. Under these partnerships, we commit to sustainable long-term growth along with our client partners, offering flexibility to adapt to changes in their development and manufacturing requirements, while still simplifying our own planning and allocation of resources. The approach ensures that capacity, staff, and equipment are ready when needed for our partners’ programs without interrupt of other ongoing projects at our site, in a manner that is quickly and easily scalable to meet future demands. Such partnerships offer considerable benefits both to Rentschler Biopharma and our partner companies, as well as to the ultimate beneficiaries of all the work we do: the patients.
The company was founded in 1927 and has been developing bioprocesses and producing biopharmaceuticals since 1974. We received the first marketing approval for interferon in 1983 and in 1997 and became an outsourcing pioneer and one of the first true CDMOs. We have been innovating to find new ways to support our clients ever since. For instance, we were among the first companies to install 1,000-L SU bioreactors and produce commercial batches in a 2,000-L SU bioreactor. We have nearly 50 years of proven expertise in biotechnology, having manufactured over 300 client molecules, with strengths in highly complex molecules, fusion proteins, and recombinant enzymes, as well as monoclonal and multi-specific antibodies, among other modalities. Over 10% of the molecules that we have worked on have already made it to the market, and many more are progressing through preclinical to phase III clinical development.
As a fifth-generation family-owned company, we can be rapidly decisive, implement innovative programs, and build long-term sustainability without the bureaucratic barriers that sometimes exist in larger, public corporations. Our organization is free to plan without focusing on short-term financial profit. The innovative spirit of our leadership has positioned us at the forefront of new developments in biopharma.
At Rentschler Biopharma, we know that our employees are the key to realizing the vision of the company and to our continuous, sustainable success. That is why we attach great importance to the personal and professional development of each employee — individually and over the long term. Staying true to our motto — "Many hands, many minds, one team!" — I am grateful and proud to have such a great team, and I thank them for their fantastic contribution. For three consecutive years, we have been recognized as one of “Germany’s most attractive employers” by the F.A.Z. Institute, this year — for the first time — ranking first in the biopharma sector. I think this achievement speaks for itself!
In 1991, Dr. Frank Mathias, a freshly graduated French pharmacist of the Paris VI University, entered the German pharmaceutical industry, the largest at the time. Since then, he was able to experience different corporate and leadership cultures in multiple management positions: from then global giant Hoechst AG, via family-owned French Servier, followed by American top Biotech Amgen, to publicly listed German Medigene AG — leading him to Rentschler Biopharma SE as CEO in 2016. As Chairman of vfa bio, he is representing German biotech industry interests. Frank champions long-term strategic growth in the biopharmaceutical industry.