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C-stemGMP SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 C-stemGMP project word cloud

Explore the words cloud of the C-stemGMP project. It provides you a very rough idea of what is the project "C-stemGMP" about.

supplier    chronic    time    affordable    viability    24    industrial    fda    programs    pluripotent    degenerative    instrument    tft    strategy    stemtm    patients    underway    human    2025    rare    outpace    scalable    market    treefrog    therapies    2012    raw    volume    cell    provides    pme    clinical    scaling    cells    mass    anticipates    medicine    financial    laquo    capacity    approve    replace    invested    pharmaceutical    boomed    position    manufacturing    compliant    material    regenerative    models    encapsulates    pharmas    months    practices    meet    quality    materials    standard    2018    alliance    big    2bn    gene    diseases    settings    therapy    raquo    good    players    culture    clients    killing    device    secure    stem    trials    consolidate    global    outstanding    standards    encapsulation    therapeutics    relations    healthcare    certified    agencies    safety    suffering    benefits    treatments    regulatory    multiplication    economic    capture    failing    tissues    gmp    vision    bottleneck    baseline    cellular    industry    critical    incurable    028   

Project "C-stemGMP" data sheet

The following table provides information about the project.

Coordinator
TREEFROG THERAPEUTICS 

Organization address
address: 146 RUE LEO SAIGNAR BATIMENT
city: BORDEAUX
postcode: 33000
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Total cost 3˙382˙855 €
 EC max contribution 2˙367˙998 € (70%)
 Programme 1. H2020-EU.3. (PRIORITY 'Societal challenges)
2. H2020-EU.2.3. (INDUSTRIAL LEADERSHIP - Innovation In SMEs)
3. H2020-EU.2.1. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies)
 Code Call H2020-SMEInst-2018-2020-2
 Funding Scheme SME-2
 Starting year 2019
 Duration (year-month-day) from 2019-11-01   to  2021-10-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    TREEFROG THERAPEUTICS FR (BORDEAUX) coordinator 2˙367˙998.00

Map

 Project objective

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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The information about "C-STEMGMP" are provided by the European Opendata Portal: CORDIS opendata.

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