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December 8, 2025BloodOpen Access

Current practices, organizational structures, technologies and challenges in developing atmps: A survey by dare-NL, nxtgen hightech, T2EVOLVE and ctiwp of EBMT - a gocart-coalition initiative

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Authors

ADAnil DeshantriUtrecht UniversityGRGeetha RameshUniversity of MadrasABAnny BallardiniUtrecht University

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Implication

Survey reveals challenges in clinical trials and manufacturing of advanced therapy medicinal products in Europe, indicating a need for improved processes.

Key Points

  • This research aims to map current practices and challenges in the development of advanced therapy medicinal products (ATMPs) across Europe.
  • Developed a 371-question SurveyMonkey questionnaire to assess ATMP production activities from 2021 to 2023
  • Survey distributed to academic, non-profit, and commercial facilities involved in (pre-)GMP-grade ATMP production
  • Analysis focused on organizational structures, technologies, and challenges in ATMP facilities across Europe.
  • Responses collected from 92 facilities across 33 countries, with 75 from Europe
  • Common challenges included cost, regulatory compliance, and process adaptation
  • Leukapheresis, bone marrow, and stem cells were frequently cited as cell sources for ATMPs

Cite This Study

Deshantri et al. (2025) studied this question.

synapsesocial.com/papers/69362f5a4fa91c937236db40https://doi.org/10.1182/blood-2025-5961
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  4. 4Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU2026 · 1 citations
  5. 5Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status2026 · 1 citations