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C-stemGMP

Financiado

Cerrado

c GMP compliance of C stem an IPSc based cell therapies production technology

Scaling-up cell therapy manufacturing provides many benefits: the capacity to replace failing tissues in patients suffering from incurable chronic or degenerative diseases, affordable treatments and the economic viability of the d... ver más

31/10/2021

TFT

3M€

Presupuesto del proyecto: 3M€

Líder del proyecto

TREEFROG THERAPEUTICS No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2021-10-31

EIC-SMEInst-2018-2020: SME instrument

I+D

Cerrada hace 7 años

0% 70% 100%

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

1 Participantes

TFT

2.37M€ | Lider

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Duración del proyecto: 23 meses Fecha Inicio: 2019-11-28
Fecha Fin: 2021-10-31

Líder del proyecto

TREEFROG THERAPEUTICS No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 3M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Scaling-up cell therapy manufacturing provides many benefits: the capacity to replace failing tissues in patients suffering from incurable chronic or degenerative diseases, affordable treatments and the economic viability of the development of cell therapies for rare diseases. The baseline of TreeFrog Therapeutics (TFT), Cell Therapy for All, encapsulates this vision.TFT has already obtained outstanding results with its C-StemTM stem cell culture technology, fully scalable and allowing a high cell multiplication factor. The cell therapy market has boomed since 2012. In 2018, 1,028 clinical trials were underway according to the Alliance for Regenerative Medicine and big pharmas invested €6.2bn in cell therapy programs. The FDA anticipates to approve « 10 to 20 cell and gene therapy products a year » by 2025. A critical bottleneck remains for the cell therapies that will reach the market within 5 to 10 years: the industrial production of human induced pluripotent stem cells, the raw material for cell therapies. Current manufacturing models do not meet the standards of regulatory authorities and healthcare systems in terms of safety, cost, volume and lead time. With C-StemTM, TFT is in the best position to become the global supplier of stem cells for cell therapy’s industry. Tailored for cost-killing mass-production of stem cells, while defining a new quality standard for cellular products, C-StemTM needs to be certified for Good Manufacturing Practices (GMP) to be used in clinical settings and capture its market. This project requires, within 24 months, to develop a GMP encapsulation device, to replace non-compliant materials, while developing relations with EU/US regulatory agencies and clients from the pharmaceutical industry. TFT has a go-global strategy and aims at leading its market within 7 years. Funding from the H2020 Instrument PME Phase 2 would secure the project and consolidate TFT on the financial level, a key element to outpace non-european players.

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