Resolve BioSciences GmbH

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Further Collaborations Rentschler Biopharma SE

Erwin-Rentschler-Str. 21 88471 Laupheim Germany Dr Cora Kaiser (Senior Director Corporate Communication) +49-7392-701-0 +49-7392-701-300 communications@ rentschler-biopharma.com www.rentschler-biopharma.com

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1,100 1927 S1

| Contract development and manufacturing organization (CDMO) for biopharmaceuticals | Cell and Gene Therapy Services with Rentschler ATMP Ltd

Strategic alliance with Leukocare AG, located in Munich, Germany, for bestin-class formulations

Strategic collaboration with Vetter, headquartered in Ravensburg, Germany, for high quality aseptic filling and secondary packaging

Rentschler Biopharma offers bioprocess development and cGMP manufacturing solutions from concept to market for pharma and biotech companies in long-term collaborations and strategic collaboration settings.

A world-class biopharmaceutical CDMO

Rentschler Biopharma is a leading global contract development and manufacturing organisation (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals. The company’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. Rentschler Biopharma is a familyowned company with about 1,100 employees. In Stevenage, UK, Rentschler Biopharma launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.

Your trusted partner from concept to market

Rentschler Biopharma’s end-to-end offering includes biopharmaceutical process development and manufacturing as well as related consulting activities such as project management and regulatory support. Rentschler Biopharma is highly experienced in the development and cGMP manufacturing of monoclonal antibodies, designer proteins, and other therapeutic proteins in compliance with international standards (EMA/FDA). Since 2020, the company has expanded into the promising field of mRNA production. Working collaboratively with its clients, Rentschler Biopharma provides customised solutions with optimised work packages for each development stage. State-of-the-art cGMP facilities and cell culture processes are leveraged for manufacturing for both, clinical studies and commercial supply. Consistent monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC), ensures that each project is properly documented in accordance with international regulatory requirements. In order to offer value-adding solutions across the entire process chain, the company has entered into a strategic alliance with Leukocare for formulation development. Another strategic collaboration is with Vetter for aseptic manufacturing and packaging. The desired goal of the collaboration with Vetter is the alignment of manufacturing approaches that enable clients to bring their products to patients more easily and faster.

Bioprocess development

› Fast and efficient supply for multiple candidate screening › Robust and scalable CHO cell lines for cGMP manufacturing › Efficient cell culture and purification processes › Well-established analytical methods › Advanced formulation development exclusively by

Leukocare AG

Best-in-class formulation development

Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. Operating at the interface of drug substance and drug product development, Leukocare combines sound knowledge of biopharmaceutical formulation development with bioinformatics and biostatistics. Thus, bioinformatics, biostatistics and design of experiment (DoE) are combined at Leukocare to explore a broader design space than conventional approaches in order to reach optimal formulations in less time at lower costs.

cGMP biomanufacturing

› Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L › Flexible single-use bioreactor lines up to 2,000 L › State-of-the-art purification processes › Guaranteed product quality and purity in accordance with cGMP guidelines › Four new 2,000 L single-use bioreactors will be added by late 2023

As a world-class solution provider, we ensure optimum time-to-clinic and time-to-market by accelerating timelines to create competitive advantage for our clients. For seamless market approval, we consult and assist clients with regulatory queries, develop optimised strategies, and generate complete documentation for approval of clinical studies and market launch.