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  4.  » RheinCell Therapeutics Achieves Milestone GMP Certification to Manufacture Cord Blood-Derived iPSCs for Safe and Compliant Cell Therapies
“In August 2021, Catalent completed the acquisition of RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs). Prior to the acquisition, RheinCell first announced, in September 2020, that it had achieved GMP certification and Manufacturing Authorization to supply clinical-grade iPSCs. At the time, RheinCell made the following announcement:

RheinCell Therapeutics Achieves Milestone GMP Certification to Manufacture Cord Blood-Derived iPSCs for Safe and Compliant Cell Therapies

We are proud to announce that Rheincell has GMP certification and Manufacturing Authorization to supply clinical-grade iPSCs and thus, make a meaningful contribution to advancing cell therapies.

A special thank you goes out to our team who worked tirelessly to achieve this milestone.

RheinCell Therapeutics GmbH, a developer and manufacturer of human induced pluripotent stem cells (iPSCs) as starting materials for cell therapies, announced it has received Good Manufacturing Practice (GMP) certification and Manufacturing Authorization. This marks a landmark achievement for RheinCell, which is now among a select few iPSCs manufacturers to have received the critical certification.

The certificate and accompanying manufacturing permit — which were granted following inspection of RheinCell’s manufacturing facilities in September 2020 — confirm that the company’s site follows the GMP principles of the European Union for human medicinal products (2003/94/EC), including requirements for chemical, physical, and biological quality control testing.

“We have reached another milestone in the evolution of our company – one that was borne from the foresight of our manufacturing and quality control teams, and the tremendous work of everyone involved in building an efficient production strategy,” said Jürgen Weisser, CEO of RheinCell. “RheinCell is now one of very few commercial enterprises worldwide that are certified to produce iPSCs – a critical starting material for stem cell-based therapies – in a regulated and GMP-compliant process and environment.”

Heading up the certification efforts was Dr. Katja Aschermann, COO of RheinCell. “At RheinCell, we are proud to implement state-of-the-art, GMP-compliant manufacturing processes to meet the needs of our international customers for ready-to-use, fully characterized clinical-grade iPSC lines,” explained Aschermann.

The GMP certification and Manufacturing Authorization pave the way for the company to deliver fully characterized clinical-grade iPSCs that are derived from human cord blood cells for the development of cell-based therapies. Furthermore, RheinCell has the technology, facilities, know-how and processes to manufacture, expand, differentiate and cryopreserve these cell lines according to specific development needs.

ABOUT CATALENT CELL & GENE THERAPY

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 U.S. and Europe.

ABOUT CATALENT

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.

With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.

Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.

 

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