Global Excellence in Biomanufacturing: Fueled by 150 Years of Creating Value Sustainably

Rentschler Biopharma headquarters in Laupheim, Germany

Rentschler Biopharma began its role as a contract development and manufacturing organization (CDMO) for biopharmaceuticals in 1997. Founded in 1872 as a pharmacy in Laupheim, Germany, the company transitioned to pharmaceutical manufacturing, then branched out into biotechnology, and ultimately channeled its expertise and experience into becoming a global CDMO. Our success over the past 150 years has been based on a strong foundation of creating value sustainably, and that has paved the way for further advancement and success. As a reliable partner and a passionate enabler, Rentschler Biopharma transforms innovative ideas into life-saving biopharmaceuticals. By connecting experts, experience, and expertise, we are mastering complex problems to achieve the best solutions.

Today, we are a globally leading, premium full-service company that understands the complexity of biopharmaceutical manufacturing. We leverage our long-standing expertise to create value sustainably for clients and patients. That has been key to the company’s success.

We are proud and truly humbled to have played our part in supporting about 160 clients and their patients by addressing both clinical and commercial needs. We have an extensive track record of almost 50 years of CDMO experience that has ensured the highest quality products from concept to market. We will continue our dedication to working with a broad range of modalities, including complex formats such as designer proteins, bispecific antibodies, and newer modalities such as advanced therapy medicinal products (ATMPs) and mRNA-based therapies. We are proud to share our insights into the innovations and technologies that have shaped the past two decades as well as our perspective on where the biomanufacturing and CDMO industries are heading.

Upcoming RBMC-US multiproduct facility in Milford, MA, USA

Evolution of Today’s Biomanufacturing Industry
Both bioprocess development and current good manufacturing practice (CGMP) production have developed consistently over the past 20 years, and a number of factors have contributed to that evolution. Implementation of single-use technologies in biomanufacturing has been a game changer. Small or medium-sized bioreactors up to 3,000 L have played important roles in biopharmaceutical production because single-use technology enables quick changeover and efficient timelines. Small and medium-sized scales are ideal for producing therapies for patients with serious and rare diseases. As biomanufacturers fulfill the world’s need for personalized medicines, single-use technologies will continue to shape the industry. That is why we expanded the 2,000-L bioreactor capacity at our headquarters in Laupheim, Germany, in 2021.

We also invested in four 2,000-L single-use bioreactors at our site in Milford, MA, United States. Our new facility, the Rentschler Biopharma Manufacturing Center US (RBMC-US), will expand CGMP manufacturing capacity significantly, accelerating clinical and commercial supply of essential biopharmaceuticals. That will add 22,000 ft² of manufacturing cleanroom space. The site will be highly automated and leverage industry 4.0 solutions, providing innovative digital and analytical services. We expect the RBMC-US site to be operational in late 2023.

Rentschler ATMP in Stevenage, UK, specializes in viral vector manufacturing for clinical supply

Without a doubt, digitalization and automation are changing how everyone in the biopharmaceutical industry works and lives today. Continuous optimization of operational fitness always has been an integral part of our strategy. We are moving toward a paperless, less hands-on way of working that ensures that the high quality that it adheres to during process development and manufacturing also is reflected in our data integrity. A solid data foundation can be beneficial to both CDMOs and clients. We offer a high level of transparency to our clients and to regulators. Ultimately, that goes a long way in streamlining a product’s path to market while ensuring high quality and patient safety.

Collaborations: The COVID-19 pandemic has changed our world view at many levels and has affected the speed at which regulatory approvals take place. The entire industry — including regulatory authorities, biomanufacturers, and suppliers — has demonstrated what can be achieved when all parties are committed to one unifying purpose. Collaboration is part of our DNA at Rentschler Biopharma, and we always have believed in the power of cooperation instead of competition. With that belief, we have forged strong strategic alliances to offer best-in-class services to our clients. Ultimately, collaboration at all levels has been key to achieving remarkable and commendable feats during the COVID-19 pandemic, and that holds promise for our industry. Learnings from the pandemic will continue to shape and influence the way our industry interacts and operates in the years to come. We hope that they also will positively influence regulatory pathways and open the door for new modalities such as ATMPs. That will help in advancing the entire biopharmaceutical industry and bring us closer to our joint goal of developing life-changing therapies.

Shaping the Future of Next-Generation Biomanufacturing
As the biopharmaceutical landscape continues to evolve, agility and a high degree of flexibility will be essential to keeping ahead of the curve while making meaningful contributions to the industry. As a midsized, family-owned company, Rentschler Biopharma lives that objective through its entrepreneurial spirit, which has enabled us to take calculated risks while ensuring that we continue to create value sustainably. Furthermore, we have benefited from a visionary corporate strategy that is not based on financial key performance indicators (KPIs). We seek excellence, and our team is convinced that success is a by-product of that spirit. That helps us to support our clients — and ultimately patients who are affected by serious and rare diseases

Complex biopharmaceutical formats and new modalities such as mRNA therapies and ATMPs will continue to build on their strong position in the near future. Keeping that in mind, we set up Rentschler ATMP (our center of excellence for ATMPs) in Stevenage, UK, which is Europe’s largest cell and gene therapy hub. Currently, our highly experienced team is ramping up our facility for the state-of-the-art manufacturing of viral vectors for clinical supply. For some patients, such modalities are the only therapies that offer the promise of an improved quality of life or even a cure. Biomanufacturers with the expertise and foresight to invest in such drug products will be able to shape the future of those exciting fields.

Collaborations across the biopharmaceutical and CDMO industries could become the norm in the short term. Rentschler Biopharma is part of a strong strategic alliance and offers best-in-class services that complement our service portfolio, which spans the entire biopharmaceutical value chain.

Supply chains also will be monitored even more closely in the future. As an industry, we must redesign our thinking to be more sustainable, resilient, and ready to address future challenges. The biopharmaceutical industry will seek to partner, regionally and globally, to find sustainable solutions to supply-chain problems. Ultimately, global and equitable access to medicines will guide all such decisions as an industry.

In the future, the role of CDMOs in the industry will continue to gain prominence. Having a strong CDMO on your side not only gives you access to premium bioprocess development and manufacturing solutions, it also provides an expert to consult, guide, and advise you in making the right decisions to bring your product to clinic, market, and patient efficiently. At Rentschler Biopharma, we treat our clients as true partners and our operations as an extension of their pipelines. Ultimately, we build long-term strategic relationships based on transparency, active communication, and mutual trust.

Christiane Bardroff is senior vice president of client program management and senior vice president of clinical and commercial manufacturing at Rentschler Biopharma SE; [email protected].