Rentschler Biopharma expands production of highly complex antibodies at German site

• Manufacturing capacity for biopharmaceuticals is important benchmark for Germany as a biotechnology location, according to yesterday's Biotech Report published by vfa bio and Boston Consulting Group
• Rentschler Biopharma expands production capacity with 2,000-liter bioreactor to address increasing demand for complex antibodies, a class of biopharmaceutical drugs with continued high potential
• Flexible solutions for development and local production of complex drugs for serious and rare diseases are an important factor in public health

Laupheim, Germany, June 30, 2021 - Antibody therapies have become an integral part of treating serious and rare diseases. "It is all the more important that we have a high level of expertise in drug development as well as in bioprocess development and production of therapeutic antibodies," said Dr. Frank Mathias, CEO of Rentschler Biopharma SE, on the occasion of presenting the annual industry report "" by Boston Consulting Group (BCG) and vfa bio, Germany's industry association for research-based biotechnology companies, which took place yesterday in Berlin.

While Germany scored an impressive second place* behind the US in terms of the number of manufactured biopharmaceutical active ingredients approved in the EU, the country is falling behind in a global comparison of production capacity: While Germany achieved third place in 2018, it only ranked fifth in 2021. Rentschler Biopharma is in the process of expanding its 2,000-liter bioreactor production capacity.

"For most biopharmaceuticals currently in development, this size of bioreactor offers maximum flexibility for both clinical- and commercial-scale manufacturing, making it the optimal platform for our business at Rentschler Biopharma," explained Dr. Mathias. "We focus on supporting our clients in the development of highly complex molecules, manufacturing them safely and under the highest quality standards. We thus are making a significant contribution to the availability of life-saving therapeutics."

Producing more than 110 different therapeutic protein formats, including monoclonal and multi-specific antibodies as well as antibody derivatives, Rentschler Biopharma has thorough development and production know-how in this pioneering technology. The pivotal role of antibodies in modern healthcare to treat serious or chronic diseases is also reflected in the number of molecules approved as of the end of 2020: According to the Biotech Report, nearly one-third of newly approved compounds in Germany were antibodies. This technology platform will continue to gain importance in the coming years: Accounting for 65% of all clinical development candidates, recombinant antibodies represent the majority of biopharmaceutical substances in clinical development.

"Looking at the compounds currently in the pipeline, the antibodies approved to date, and the experience gained during the pandemic and previously with complex global value chains, we must ensure that patients with serious diseases have optimal access to innovative therapies. This is where Germany should see its great potential, invest further, and continue to play a leading role worldwide," said Dr. Mathias, explaining the company's plan to use the new 2,000-liter bioreactor capacity to produce novel antibody therapies or other active ingredients against serious or rare diseases.

In addition to process development and production on behalf of clients, Rentschler Biopharma also offers consulting services for the development of new drugs, from cell line selection to regulatory processes, based on decades of expertise and many successfully completed projects. Rentschler Biopharma is thus an experienced partner for both young and established companies.

_{* Production sites of biopharmaceuticals centrally approved in the EU by number of active ingredients - USA: 102, Europe, incl. Switzerland and UK: 165, including Germany as market leader: 44.}

About Rentschler Biopharma SE
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. 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. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with about 1,000 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. In Stevenage, UK, Rentschler Biopharma has launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.

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