Catalent to Acquire RheinCell Therapeutics, Strengthening a Path Toward Industrialization of Induced Pluripotent Stem Cell-Based Therapies

Catalent recently announced it has reached an agreement to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs). Upon completion, the acquisition will build upon Catalent’s existing custom cell therapy process development and manufacturing capabilities with proprietary GMP cell lines for iPSC-based therapies. The deal will enable Catalent to offer the building blocks to scale iPSC-based cell therapies while reducing barriers to entry to the clinic for therapeutic companies and is expected to close before the end of 2021, subject to customary conditions. Financial details of the transaction have not been disclosed.

iPSCs are cells that can be differentiated into various cell types to address a wide range of therapeutic indications. Founded in 2017, RheinCell has undertaken significant research and development of full GMP human leukocyte antigen (HLA)-matched cell banks with superior genomic integrity, as well as investing in development-scale operational capabilities. RheinCell is based in Langenfeld, near Düsseldorf, Germany. Upon closing, RheinCell’s current employees will join Catalent’s Cell & Gene Therapy business.

“We formed RheinCell based on our deep scientific and regulatory expertise in the promising field of cell-based therapies,” commented Juergen Weisser, Chief Executive Officer, RheinCell Therapeutics. He added, “We are convinced Catalent will be able to substantially accelerate RheinCell’s future growth and help to support customers around the globe that are interested in our GMP-grade iPSC lines and iPSC-based services to feed their development pipelines in this exciting and highly demanding new therapeutic field.”

“By offering a renewable, and standardized, source of cells for further product development, iPSCs have the potential to be a disruptive technology that could fuel the development of the next generation of cell therapies and substantially enhance the ability to manufacture at scale,” said Julien Meissonnier, Vice President and Chief Scientific Officer, Catalent. He added, “Catalent is committed to building a full-scale value chain for emerging modalities and accelerating their path to market through expertise and innovation. This acquisition further strengthens Catalent’s position in these new therapeutic areas, by pioneering tools and techniques to substantially advance scale-up to meet the demands of clinical and commercial manufacturing.”

“This latest acquisition fuels the extraordinary growth of Catalent Cell & Gene Therapy, and the expertise and deep knowledge in iPSC cell lines that RheinCell brings will immediately boost our cell therapy portfolio, allowing us to offer iPSC banks to our customers as a premium source for their therapeutic development pathway,” said Manja Boerman, PhD, President, Catalent Cell & Gene Therapy. She added, “The addition of the RheinCell team to our growing cell therapy network will create an opportunity to share cutting-edge expertise across our global centers of excellence.”

Since 2020, Catalent has invested in its cell therapy capabilities with four strategic expansions at its Gosselies, Belgium, campus – the location of its European Center of Excellence for cell and gene therapy. Together with its US cell and gene therapy facilities across Texas and Maryland, Catalent continues to increase its clinical and commercial-scale manufacturing capabilities across the full range of cell and gene therapy activity.

RheinCell develops and manufactures GMP-grade human induced pluripotent stem cells (iPSCs) for the next generation of cell therapies. Its production pipeline focuses on high immune compatibility and low rejection potential, with a spotlight on solutions for off-the-shelf, allogenic therapeutics. RheinCell provides exclusive access to clinically approved and consented cord blood cells, proprietary cell reprogramming protocols, state-of-the-art cleanroom and cell culture facilities, GMP-compliant manufacturing processes, and a first-class community of iPSC workflow experts who also develop GMP-compliant differentiation protocols in close cooperation with customers. For more information, visit www.rheincell.de

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the US and Europe.

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.