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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.

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

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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