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The expanding role of blood and tissue establishments in the development of advanced therapy medicinal products.
Horan, Aisling; Warreth, Shada; Hervig, Tor; Waters, Allison.
Afiliación
  • Horan A; Irish Blood Transfusion Service, National Blood Centre, Dublin, Ireland.
  • Warreth S; School of Chemical and Pharmaceutical Sciences, Technological University Dublin, Dublin, Ireland; National Institute for Bioprocessing Research and Training (NIBRT), Co., Dublin, Ireland.
  • Hervig T; Irish Blood Transfusion Service, National Blood Centre, Dublin, Ireland; School of Medicine, Trinity College Dublin, Dublin, Ireland.
  • Waters A; Irish Blood Transfusion Service, National Blood Centre, Dublin, Ireland; UCD School of Public Health, Physiotherapy and Social Science, University College Dublin, Dublin, Ireland. Electronic address: Allison.waters@ibts.ie.
Cytotherapy ; 26(5): 524-530, 2024 05.
Article en En | MEDLINE | ID: mdl-38441513
ABSTRACT
BACKGROUND

AIMS:

The relationship between blood establishments and advanced cellular therapies is evident in several European countries, with some involved in research and development and/or in manufacturing. The aim of the present study was to understand the advanced therapy medicinal product (ATMP) infrastructural, regulatory and logistic requirements needed for the Irish Blood Transfusion Service to support advanced therapeutics in Ireland.

METHODS:

An online survey consisting of 13 questions was distributed in a targeted manner to the identified ATMP stakeholders in Ireland, namely those working in industry, health care, regulatory agencies or education. Subject matter experts in the field were approached and interviewed to gain further insight into the relationship between blood and tissue establishments (BTEs) and ATMPs, to explore the advantages these institutions have in development and to highlight potential challenges for implementation.

RESULTS:

In total, 84.9% of survey respondents stated that BTEs have a role in the development of advanced therapeutics. Key BTE services identified as applicable to the ATMP sector from both surveys and interviews include the provision of starting materials for research and manufacturing, donor management, use of existing quality and traceability frameworks, product logistic strategies and Good Manufacturing Practice. Challenges for BTE expansion into the sector currently include high costs associated with ATMPs, lack of expertise in these therapies, limited therapeutic populations and no national ATMP strategic plan for Ireland.

CONCLUSIONS:

Blood establishments have services and expertise that can be extended into the advanced therapy sector. The existing knowledge and skill base of BTEs in Ireland should be leveraged to accelerate the development of ATMP strategies for industry and healthcare.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tratamiento Basado en Trasplante de Células y Tejidos Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Cytotherapy Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Irlanda Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tratamiento Basado en Trasplante de Células y Tejidos Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Cytotherapy Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Irlanda Pais de publicación: Reino Unido