Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes

Autor: Salvatore Pasqua, Maria Concetta Niotta, Giuseppina Di Martino, Davide Sottile, Bruno Douradinha, Monica Miele, Francesca Timoneri, Mariangela Di Bella, Nicola Cuscino, Chiara Di Bartolo, Pier Giulio Conaldi, Danilo D’Apolito

Publikováno v: Molecular Therapy: Methods & Clinical Development, Vol 22, Iss , Pp 320-329 (2021)

Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparati

Externí odkaz: https://doaj.org/article/003d1bb7774b440285018e95821eda62

Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes

Autor: Francesca Timoneri, Maria Concetta Niotta, Davide Sottile, Mariangela Di Bella, Bruno Douradinha, Chiara Di Bartolo, Giuseppina Di Martino, Danilo D'Apolito, Salvatore Pasqua, Monica Miele, Pier Giulio Conaldi, Nicola Cuscino

Publikováno v: Molecular Therapy: Methods & Clinical Development, Vol 22, Iss, Pp 320-329 (2021)
Molecular Therapy. Methods & Clinical Development
Molecular Therapy: Methods & Clinical Development, Vol 23, Iss, Pp 567-568 (2021)

Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9084e1afe727ed379e59cb145bb9923a
http://www.sciencedirect.com/science/article/pii/S2329050121000863

Strategy and validation of a consistent and reproducible nucleic acid technique for mycoplasma detection in advanced therapy medicinal products

Autor: Pier Giulio Conaldi, Lucia D'Aiello, Bruno Douradinha, Giuseppina Di Martino, Danilo D'Apolito, Chiara Di Bartolo, Lucia Pecoraro, Salvatore Pasqua, Floriana Barbera

Publikováno v: Biologicals. 64:49-57

Advanced therapy medicinal products (ATMP) are required to maintain their quality and safety throughout the production cycle, and they must be free of microbial contaminations. Among them, mycoplasma contaminations are difficult to detect and undesir

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d58ab3684395c388c27af87cdea2279
https://doi.org/10.1016/j.biologicals.2020.01.001

A Quality Risk Management Model Approach for Cell Therapy Manufacturing

Autor: Jörg C. Gerlach, Fabio Lopez, A. Passannanti, Fabio Triolo, Chiara Di Bartolo, Bruno Gridelli, Tommaso Piazza

Publikováno v: Risk Analysis. 30:1857-1871

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guid

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e26e69f0196cf76c974becb7de354d83
https://doi.org/10.1111/j.1539-6924.2010.01465.x

Structural and rheological characterization of hyaluronic acid-based scaffolds for adipose tissue engineering

Autor: Assunta Borzacchiello, Laura Mayol, Andrea Pastorello, Luigi Ambrosio, Piera A. Ramires, E. Milella, Chiara Di Bartolo

Publikováno v: Biomaterials 28 (2007): 4399–4408. doi:10.1016/j.biomaterials.2007.06.007
info:cnr-pdr/source/autori:A. Borzacchiello; L. Mayol; P.A. Ramires; C. Di Bartolo; A. Pastorello; L. Ambrosio; E. Milella/titolo:Structural and rheological characterization of hyaluronic acid-based scaffolds for adipose tissue engineering/doi:10.1016%2Fj.biomaterials.2007.06.007/rivista:Biomaterials/anno:2007/pagina_da:4399/pagina_a:4408/intervallo_pagine:4399–4408/volume:28

In this study the attention has been focused on the ester derivative of hyaluronic acid (HA), HYAFF ® 11, as a potential three-dimensional scaffold in adipose tissue engineering. Different HYAFF ® 11 sponges having different pore sizes, coated or n

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cc1ee739179522d83622bd8dc3fd95d4
https://pubmed.ncbi.nlm.nih.gov/17602736