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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.

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

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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