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European Biopharmaceutical Review

The Green Shoots of Tomorrow’s Cell Therapies

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines a starting material as: “a raw material, intermediate, or an active pharmaceutical ingredient (API) that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement or produced in-house. API starting materials are normally of defined chemical properties and structure”. Cells are commonly used in biopharmaceutical manufacturing as a raw material and in the particular case of cell lines that serve as a starting point for cell therapies, that raw material itself becomes the API.

Induced pluripotent stem cells (iPSCs) are gaining traction as starting materials for a new generation of regenerative and immune cell therapies. Coaxed to a state that is indistinguishable from embryonic stem cells, iPSCs can be derived from ordinary cells of the body donated as biopsies or blood samples. Demonstrably pluripotent, iPSCs can potentially be differentiated into any cell type needed. Finally, with well-defined culturing, manipulation, and cryopreservation protocols, iPSC lines can be preserved indefinitely as an inexhaustible source of cellular material.

Whether generated at the hand of the therapy developer or purchased from a dedicated supplier, iPSCs destined for clinical applications are manufactured under certified Good Manufacturing Practice conditions and meet stringent quality criteria aimed at guaranteeing their safety for patients and comparability across cell lines. Perhaps less obvious than the advances that have pushed iPSCs toward clinical quality, are the ongoing efforts of therapy developers to explore the expansion options of allogeneic strategies. The concept of an ‘off-the-shelf’ starting material for cell therapies that are relevant for broad fractions of the human population and that may target multiple unmet indications is where the unique potential of iPSCs truly lies.

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Thomas Marx, Chief Commercial Officer, has over 25 years of global commercial management and leadership experience within the biopharmaceutical industry where he gained an in-depth understanding of the scientific and regulatory environment of product and therapy development. Thomas currently leads business development strategies and partnership management at RheinCell Therapeutics GmbH.

Dr Boris Greber, Chief Scientific Officer, heads the cell production and R&D activities at RheinCell Therapeutics GmbH. Prior to this role, Boris served as an independent research group leader at the Max Planck Institute for Molecular Biomedicine. He is an internationally recognised scientist with a 15-year track record in basic and applied human iPSC research.
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