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  1. Article ; Online: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies.

    East, Amanda D / Gebo, James E T / Lau, Anna F

    Journal of visualized experiments : JoVE

    2023  , Issue 193

    Abstract: A well-validated and holistic program that incorporates robust gowning, cleaning, environmental monitoring, and personnel monitoring measures is critical for minimizing the microbial bioburden in cellular therapy manufacturing suites and the ... ...

    Abstract A well-validated and holistic program that incorporates robust gowning, cleaning, environmental monitoring, and personnel monitoring measures is critical for minimizing the microbial bioburden in cellular therapy manufacturing suites and the corresponding testing laboratories to ensure that the facilities are operating in a state of control. Ensuring product safety via quality control measures, such as sterility testing, is a regulatory requirement for both minimally manipulated (section 361) and more than minimally manipulated (section 351) human cells, tissues, and cellular and tissue-based products (HCT/Ps). In this video, we provide a stepwise guide for how to develop and incorporate the best aseptic practices for operating in a cleanroom environment, including gowning, cleaning, staging of materials, environmental monitoring, process monitoring, and product sterility testing using direct inoculation, provided by the United States Pharmacopeia (USP<71>) and the National Institutes of Health (NIH) Alternative Sterility Testing Method. This protocol is intended as a reference guide for establishments expected to meet current good tissue practices (cGTP) and current good manufacturing practices (cGMP).
    MeSH term(s) Humans ; Environment, Controlled ; Infertility
    Language English
    Publishing date 2023-03-17
    Publishing country United States
    Document type Journal Article ; Video-Audio Media ; Research Support, N.I.H., Intramural
    ZDB-ID 2259946-0
    ISSN 1940-087X ; 1940-087X
    ISSN (online) 1940-087X
    ISSN 1940-087X
    DOI 10.3791/65209
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?

    Gebo, James E T / Lau, Anna F

    Journal of clinical microbiology

    2020  Volume 58, Issue 7

    Abstract: Sterility testing of cellular therapy products along with the associated environmental monitoring requirements for aseptic facilities, including compounding pharmacies, continues to impact clinical microbiology laboratories, as evidenced by the numerous ... ...

    Abstract Sterility testing of cellular therapy products along with the associated environmental monitoring requirements for aseptic facilities, including compounding pharmacies, continues to impact clinical microbiology laboratories, as evidenced by the numerous discussions recurring on American Society for Microbiology Division C and ClinMicroNet listservs. This minireview provides an overview of this complex field of current good manufacturing practices (cGMP) based on biopharmaceutical industry standards and summarizes the compendial and alternative rapid microbial test methods available for product sterility and
    MeSH term(s) Cell- and Tissue-Based Therapy ; Clinical Laboratory Services ; Humans ; Infertility ; Laboratories ; United States
    Language English
    Publishing date 2020-06-24
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Intramural ; Review
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.01492-19
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1188: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Comparison of Five Commercial Molecular Assays for

    Totten, Arthur H / Adams, Anna Julia / Halas, Hyunmi K / Gebo, James E T / East, Amanda D / Lau, Anna F

    Journal of clinical microbiology

    2023  Volume 61, Issue 2, Page(s) e0149822

    Abstract: Testing of cellular therapy products ... ...

    Abstract Testing of cellular therapy products for
    MeSH term(s) Humans ; Mycoplasma ; Limit of Detection ; Cell Culture Techniques ; Reference Standards ; Cell- and Tissue-Based Therapy
    Language English
    Publishing date 2023-01-23
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/jcm.01498-22
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1188: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Comprehensive Evaluation of Compendial USP<71>, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants.

    England, Matthew R / Stock, Frida / Gebo, James E T / Frank, Karen M / Lau, Anna F

    Journal of clinical microbiology

    2019  Volume 57, Issue 2

    Abstract: The emergence of cell therapy programs in large academic centers has led to an increasing demand for clinical laboratories to assist with product sterility testing. Automated blood culture systems have shown promise as alternatives to the manual USP ... ... ...

    Abstract The emergence of cell therapy programs in large academic centers has led to an increasing demand for clinical laboratories to assist with product sterility testing. Automated blood culture systems have shown promise as alternatives to the manual USP<71> compendial method, but current published data are limited by small organism test sets, particularly for molds. In 2015, failure of the Bactec FX system to detect mold contamination in two products prompted us to evaluate three test systems (compendial USP<71>, Bactec FX, and BacT/Alert Dual-T) over seven different culture combinations, using 118 challenge organisms representative of the NIH current good manufacturing practice (cGMP) environment. At <96 h and <144 h for bacterial and fungal detection, respectively, the compendial USP<71> method significantly outperformed the Bactec FX system (84.7% versus 64.4%;
    MeSH term(s) Cell- and Tissue-Based Therapy/adverse effects ; Cell- and Tissue-Based Therapy/methods ; Drug Contamination ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Microbiological Techniques/methods ; Sensitivity and Specificity
    Language English
    Publishing date 2019-01-30
    Publishing country United States
    Document type Comparative Study ; Evaluation Study ; Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.01548-18
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1188: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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