Scalable Process for Cultivating Undifferentiated Stem Cells in Suspension

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This patent describes a process for cultivating undifferentiated stem cells, both embryonic and adult, in suspension using microcarriers in vessels such as spinners or bioreactors. The innovation enables large-scale, controlled, and scalable production of stem cells, maintaining their pluripotency through carefully regulated culture conditions, including intermittent agitation and optimized media. As a result, high yields of consistent quality undifferentiated stem cells can be produced for the first time in a scalable manner.

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• Production of stem cells for regenerative medicine and cell therapy, providing large numbers of pluripotent cells for transplantation or tissue engineering.
• Manufacturing of undifferentiated stem cells as a raw material for differentiation into various cell types (e.g., neural, cardiac, pancreatic) for disease modeling, drug screening, or toxicity testing.
• Development of scalable and standardized bioprocesses for stem cell banks or commercial supply of clinical-grade stem cells.
• Research in stem cell biology for understanding pluripotency and cell fate, by providing consistent quantities of undifferentiated cells.
• Personalized medicine approaches, where patient-specific stem cells can be produced in large amounts for tailored therapies.

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• Enables truly scalable production of undifferentiated (pluripotent) stem cells, overcoming limitations of traditional dishes or two-dimensional culture.
• Maintains stem cell characteristics (pluripotency) during expansion, ensuring suitability for downstream differentiation and applications.
• Highly controlled and reproducible culture conditions (temperature, oxygen, pH, agitation) provide consistent product quality.
• Reduces labor, variability, and risk of contamination compared to manual, small-scale cultures.
• Can achieve high proliferation rates (cell numbers increase several hundred percent per week), allowing rapid production and supply of stem cells.
• Versatile: works with different stem cell types (embryonic, adult), various vessel sizes (from milliliters to over 100 liters), and diverse microcarriers.
• Facilitates adaptation to clinical or GMP-compatible workflows for therapeutic applications.

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Inventors & Applicants

Patent Abstract

The invention relates to a process for cultivating undifferentiated stem cells in suspension and in particular to a method for cultivating stem cells on microcarriers in vessels. The method enables stem cells to be cultivated in a scalable process for the first time, without losing their pluripotentiality. Different types of vessels are suitable for cultivation, such as e.g. spinners and bioreactors. The option of precisely setting the cultivation conditions in said vessels aids the process of obtaining a pluripotentiality of the stem cells. the inventive method also permits large yields of stem cells of an unvarying quality to be produced.