Technical challenges for complete implementation of automated growth-based methods for microbiological examination of advanced therapy medicinal products. What's wrong with Candida albicans?-Reference-Cited by-同舟云学术

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Technical challenges for complete implementation of automated growth-based methods for microbiological examination of advanced therapy medicinal products. What's wrong with Candida albicans?

Published:2022-03 Issue:3 Volume:24 Page:320-333
ISSN:1465-3249
Container-title:Cytotherapy
language:en
Short-container-title:Cytotherapy

Author:

Rodríguez-Acosta Antonio^ORCID,Chaparro-García Jesús^ORCID,De-Toro Inmaculada^ORCID,Maldonado-Sánchez Rafael,Muñoz-Fernández Raquel,Antúnez Cristina^ORCID,Frecha Cecilia,Leyva Laura

Funder

Ministerio de Ciencia e Innovación

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference64 articles.

1. Code of Federal Regulations 2012. Title 21-Food and drugs. Chapter I-Food and Drug Administration, Department of Health and Human Services. Subchapter F- Biologics. Part 610-General biological products standards. U.S. Government Publishing, pp. 2018–2019.

2. USP71. Sterility tests. In: United States Pharmacopeia. 41th ed. National Formulary. Rockville (MD): The United States Pharmacopeial Convention, Inc; 2018.

3. Sterility (04/2011:20601). In: European Directorate for the Quality of Medicines & HealthCare (EDQM), editor. European Pharmacopoeia. 9.8th ed 07/2019, Strasbourg, France.

4. The Japanese Pharmacopoeia - Seventeenth Edition. 4.06 Sterility Test. 2016.

5. Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?;Gebo;J Clin Microbiol,2020

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