ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature

Since 2007, a new class of biologic products for human use called “advanced therapy medicinal products (ATMP)” have been legally integrated in the European Medical Agency. They consist of recombinant nucleic acid, engineered cells, cells, or tissues. In the United States, ATMP fall under the regulat...

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Autores principales: Margaux Damerval, Christine Fagnoni-Legat, Aurélien Louvrier, Sarah Fischer, Samuel Limat, Anne-Laure Clairet, Virginie Nerich, Isabelle Madelaine, Marie Kroemer
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Publicado: Frontiers Media S.A. 2021
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spelling oai:doaj.org-article:18cd314a34e54014821d82dea62b46812021-12-01T22:26:39ZATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature2296-858X10.3389/fmed.2021.713047https://doaj.org/article/18cd314a34e54014821d82dea62b46812021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fmed.2021.713047/fullhttps://doaj.org/toc/2296-858XSince 2007, a new class of biologic products for human use called “advanced therapy medicinal products (ATMP)” have been legally integrated in the European Medical Agency. They consist of recombinant nucleic acid, engineered cells, cells, or tissues. In the United States, ATMP fall under the regulatory framework of biological products and the term “cell and gene therapy product” is used in the legislative and regulatory documents. Potential clinical applications are broad, particularly, in the field of cancer, inherited genetic disease, and regenerative medicine. Indeed, the benefit conferred by CD19 chimeric antigen receptor T cells led to the first engineered cell therapy products to be approved by the Food and Drug Administration (FDA) in 2017. Gene therapy products to treat orphan diseases are also extensively developed with many clinical trials ongoing in the world. Nevertheless, the use of these therapeutic products is complex and requires careful considerations in the terms of regulatory and hospital setting requirements, such as storage, handling, administration, and disposal which justify the implementation of a secured medication circuit. Through this systematic review of the literature, the authors wanted to compile data on the assessment of environmental exposure related to the use of ATMP in healthcare setting to secure their medication circuit. A literature search was conducted on PubMed and Web of Science, and 32 publications dealing with environmental exposure assessment and ATMP were selected. In addition, marketed ATMPs were identified and data regarding the environmental concerns were extracted from product information sections from European Public Assessment Reports (EPAR). The environmental contamination assessments were mainly addressed in the reviews rather than in original articles related to the use of ATMP. Most of the product information sections from EPAR suggested precautions rather than requirements when dealing with environmental consideration following ATMP handling. Nevertheless, these precautions usually remain elusive especially concerning waste disposal and the detection of biological material on the work surfaces, and mainly relate to the genetically modified organisms (GMO) over non-GMO cellular products. Pharmaceutical oversight and adherence to the good preparation practices and good clinical practices are essential to ensure the safe use in term of environmental concern of these new therapeutic products in healthcare setting.Margaux DamervalChristine Fagnoni-LegatAurélien LouvrierAurélien LouvrierSarah FischerSamuel LimatSamuel LimatAnne-Laure ClairetVirginie NerichVirginie NerichIsabelle MadelaineMarie KroemerMarie KroemerFrontiers Media S.A.articleadvanced therapy medicinal products (ATMP)cell and gene therapy (CGT)environmental exposureenvironmental sheddingcellular therapyhealthcare settingsMedicine (General)R5-920ENFrontiers in Medicine, Vol 8 (2021)
institution DOAJ
collection DOAJ
language EN
topic advanced therapy medicinal products (ATMP)
cell and gene therapy (CGT)
environmental exposure
environmental shedding
cellular therapy
healthcare settings
Medicine (General)
R5-920
spellingShingle advanced therapy medicinal products (ATMP)
cell and gene therapy (CGT)
environmental exposure
environmental shedding
cellular therapy
healthcare settings
Medicine (General)
R5-920
Margaux Damerval
Christine Fagnoni-Legat
Aurélien Louvrier
Aurélien Louvrier
Sarah Fischer
Samuel Limat
Samuel Limat
Anne-Laure Clairet
Virginie Nerich
Virginie Nerich
Isabelle Madelaine
Marie Kroemer
Marie Kroemer
ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
description Since 2007, a new class of biologic products for human use called “advanced therapy medicinal products (ATMP)” have been legally integrated in the European Medical Agency. They consist of recombinant nucleic acid, engineered cells, cells, or tissues. In the United States, ATMP fall under the regulatory framework of biological products and the term “cell and gene therapy product” is used in the legislative and regulatory documents. Potential clinical applications are broad, particularly, in the field of cancer, inherited genetic disease, and regenerative medicine. Indeed, the benefit conferred by CD19 chimeric antigen receptor T cells led to the first engineered cell therapy products to be approved by the Food and Drug Administration (FDA) in 2017. Gene therapy products to treat orphan diseases are also extensively developed with many clinical trials ongoing in the world. Nevertheless, the use of these therapeutic products is complex and requires careful considerations in the terms of regulatory and hospital setting requirements, such as storage, handling, administration, and disposal which justify the implementation of a secured medication circuit. Through this systematic review of the literature, the authors wanted to compile data on the assessment of environmental exposure related to the use of ATMP in healthcare setting to secure their medication circuit. A literature search was conducted on PubMed and Web of Science, and 32 publications dealing with environmental exposure assessment and ATMP were selected. In addition, marketed ATMPs were identified and data regarding the environmental concerns were extracted from product information sections from European Public Assessment Reports (EPAR). The environmental contamination assessments were mainly addressed in the reviews rather than in original articles related to the use of ATMP. Most of the product information sections from EPAR suggested precautions rather than requirements when dealing with environmental consideration following ATMP handling. Nevertheless, these precautions usually remain elusive especially concerning waste disposal and the detection of biological material on the work surfaces, and mainly relate to the genetically modified organisms (GMO) over non-GMO cellular products. Pharmaceutical oversight and adherence to the good preparation practices and good clinical practices are essential to ensure the safe use in term of environmental concern of these new therapeutic products in healthcare setting.
format article
author Margaux Damerval
Christine Fagnoni-Legat
Aurélien Louvrier
Aurélien Louvrier
Sarah Fischer
Samuel Limat
Samuel Limat
Anne-Laure Clairet
Virginie Nerich
Virginie Nerich
Isabelle Madelaine
Marie Kroemer
Marie Kroemer
author_facet Margaux Damerval
Christine Fagnoni-Legat
Aurélien Louvrier
Aurélien Louvrier
Sarah Fischer
Samuel Limat
Samuel Limat
Anne-Laure Clairet
Virginie Nerich
Virginie Nerich
Isabelle Madelaine
Marie Kroemer
Marie Kroemer
author_sort Margaux Damerval
title ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
title_short ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
title_full ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
title_fullStr ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
title_full_unstemmed ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature
title_sort atmp environmental exposure assessment in european healthcare settings: a systematic review of the literature
publisher Frontiers Media S.A.
publishDate 2021
url https://doaj.org/article/18cd314a34e54014821d82dea62b4681
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