RheinCell Therapeutics Offers Fully Characterized Clinical-Grade...

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RheinCell Therapeutics Offers Fully Characterized Clinical-Grade iPSCs for Cell Therapy Development and Commercialization

By Pharma Tech Outlook | Monday, January 25, 2021

Jürgen Weisser, CEO

RheinCell Therapeutics secures milestone GMP certification to manufacture cord blood-derived iPSCs.

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

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

The company has reached another milestone in the evolution, borne from the foresight of the manufacturing and quality control teams and the tremendous work of everyone involved in developing an efficient production strategy. RheinCell is now one of the very few commercial enterprises globally that is certified to produce iPSCs, a vital starting material for stem cell-based therapies in a regulated and GMP-compliant process and environment.

Heading up the certification initiatives was Dr. Katja Aschermann, COO of RheinCell. RheinCell is proud to deploy state-of-the-art, GMP-compliant manufacturing processes to meet its international customers' requirements for ready-to-use, fully characterized clinical-grade iPSC lines.

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

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