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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.

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

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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