Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products.

Putnam, Nicole E; Lau, Anna F

Putnam, Nicole E; Lau, Anna F.

Affiliation

Putnam NE; Microbiology Service, National Institutes of Healthgrid.94365.3d, Bethesda, Maryland, USA.
Lau AF; Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Healthgrid.94365.3d, Bethesda, Maryland, USA.

J Clin Microbiol ; 59(11): e0135721, 2021 10 19.

Article in En | MEDLINE | ID: mdl-34406794

Subject(s)

Bacteria; Fungi; Culture Media; Drug Contamination; Fungi/genetics; Genetic Therapy; Humans

Key words

ATMPs; BacT/Alert; Bactec; Myco/F Lytic; advanced therapeutic medicinal products; cell therapy; fungi; gene therapy; iLYM; mold; sterility testing

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Bacteria / Fungi Type of study: Diagnostic_studies / Etiology_studies / Risk_factors_studies Limits: Humans Language: En Journal: J Clin Microbiol Year: 2021 Type: Article Affiliation country: United States

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