Validation of orthopedic allograft preparation process: a new application of media fill test

Author:

Ossato AndreaORCID,Gasperoni Carlo,Stella Michela,Montagner Giulia,Trojan Diletta,Giovagnoni Giuseppe,Giannini Michele,Realdon Francesca,Mezzadrelli Valeria,Realdon Nicola,Zuppini Teresa,Tessari RobertoORCID

Publisher

Springer Science and Business Media LLC

Subject

Transplantation,Cell Biology,Biomedical Engineering,Biomaterials

Reference19 articles.

1. Centers for Disease Control and Prevention (CDC) (2002) Update: allograft-associated bacterial infections–United States. MMWR Morb Mortal Wkly Rep 51(10):207–210

2. DeDino F, Kim V, DiNello D, Whitmer S, Adamo M, Starkey D, Evans K, Walker M, Thut D, Shields S, Van’t Hof W (2020) A cell therapy media fill protocol for validation of aseptic processing of cord blood. Cell Gene Therapy Insights 6:1529–1537

3. European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM) (2019) The Guide to the quality and safety of tissues and cells for human application. 4th edn. ISBN 978-92-871-8945-5

4. European Commission (2022) The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf. Accessed 23 January 2023

5. European Commission (2006) Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. http://data.europa.eu/eli/dir/2006/86/oj. Accessed 23 January 2023

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