Cleanrooms and tissue banking how happy I could be with either GMP or GTP?

Klykens, Johan; Pirnay, Jean‐Paul; Verbeken, Gilbert; Giet, Olivier; Baudoux, Étienne; Jashari, Ramadan; Vanderkelen, Alain; Ectors, Nadine

doi:10.1007/s10561-012-9355-8

Cited by 5 publications

(3 citation statements)

References 13 publications

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“…Many studies focus on the bacterial microbiome of intensive care units [8, 12–14], pharmaceutical clean rooms [15–17], or tissue banks [18] since their microbial composition has an impact on human health and life. Nosocomial infections acquired in hospitals and other health care facilities remain the sixth leading cause of death in the hospitals in USA [19, 20].…”

Section: Introductionmentioning

confidence: 99%

Human presence impacts fungal diversity of inflated lunar/Mars analog habitat

et al. 2017

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BackgroundAn inflatable lunar/Mars analog habitat (ILMAH), simulated closed system isolated by HEPA filtration, mimics International Space Station (ISS) conditions and future human habitation on other planets except for the exchange of air between outdoor and indoor environments. The ILMAH was primarily commissioned to measure physiological, psychological, and immunological characteristics of human inhabiting in isolation, but it was also available for other studies such as examining its microbiological aspects. Characterizing and understanding possible changes and succession of fungal species is of high importance since fungi are not only hazardous to inhabitants but also deteriorate the habitats. Observing the mycobiome changes in the presence of human will enable developing appropriate countermeasures with reference to crew health in a future closed habitat.ResultsSuccession of fungi was characterized utilizing both traditional and state-of-the-art molecular techniques during the 30-day human occupation of the ILMAH. Surface samples were collected at various time points and locations to observe both the total and viable fungal populations of common environmental and opportunistic pathogenic species. To estimate the cultivable fungal population, potato dextrose agar plate counts method was utilized. The internal transcribed spacer region-based iTag Illumina sequencing was employed to measure the community structure and fluctuation of the mycobiome over time in various locations. Treatment of samples with propidium monoazide (PMA; a DNA intercalating dye for selective detection of viable microbial populations) had a significant effect on the microbial diversity compared to non-PMA-treated samples. Statistical analysis confirmed that viable fungal community structure changed (increase in diversity and decrease in fungal burden) over the occupation time. Samples collected at day 20 showed distinct fungal profiles from samples collected at any other time point (before or after). Viable fungal families like Davidiellaceae, Teratosphaeriaceae, Pleosporales, and Pleosporaceae were shown to increase during the occupation time.ConclusionsThe results of this study revealed that the overall fungal diversity in the closed habitat changed during human presence; therefore, it is crucial to properly maintain a closed habitat to preserve it from deteriorating and keep it safe for its inhabitants. Differences in community profiles were observed when statistically treated, especially of the mycobiome of samples collected at day 20. On a genus level Epiccocum, Alternaria, Pleosporales, Davidiella, and Cryptococcus showed increased abundance over the occupation time.Electronic supplementary materialThe online version of this article (doi:10.1186/s40168-017-0280-8) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Human presence impacts fungal diversity of inflated lunar/Mars analog habitat

et al. 2017

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“…This facility strictly meets our needs and is compliant with the EU recommendations/regulation and quality standards for cardiovascular tissue banking. Permanent monitoring of the work environment is performed accordingly (during rest and activity) (Euro-GTP 2007, Jashari et al 2004;Klykens et al 2013;Zahra et al 2019a) (Fig. 2).…”

Section: Infrastructure and Critical Equipmentmentioning

confidence: 99%

Transplantation of cryopreserved human heart valves in Europe: 30 years of banking in Brussels and future perspectives

Jashari

2021

Cell Tissue Bank

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For over 30 years, our TE has processed, controlled for quality and distributed cryopreserved allograft valves for human application. We present a review of this activity and future perspectives of cardiovascular tissue banking. The donor age and medical/behavioral history are in compliance with the regulations of the EUMS. Allograft morphology and function are evaluated in a class A cleanroom. Tests for viral/bacterial infection, histological control of structure/infection/malignancy and control-rate cryopreservation are performed. A total of 7562 hearts were sent to our TE, whereas 7290 valves (pulmonary, aortic and mitral) were transplanted. The donations increased over time: 1934, 2566 and 3062 hearts were donated during the first, second and third decades (increases of 32.7 and 19.3% during the second and third decades). Likewise, there was a significant increase in transplantations with 2050, 2550 and 2690 valves implanted during the first, second and third decades (24.4 and 5.5% increase during the second and third decades). A total of 4475 pulmonary (61.4%), 2760 aortic (37.9%) and 55 mitral valves (0.7%) were transplanted. Outstanding long-term results in adults and evidence of immune-related deterioration of allografts in neonates and infants were demonstrated. Decellularization was suggested as a solution. One hundred pulmonary and 180 aortic valves were sent for transplantation after decellularization for the ESPOIR and ARISE clinical trials and beyond. The donation and transplantation activity increased progressively. Although cryopreserved valves represent the best substitute for diseased valves, accelerated failure appears after implantation in neonates and infants. The implementation of new technologies, such as decellularization, as a standard procedure for treatment of allograft valves will offer further improvements in allograft quality and increase of durability.

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“…have been developed and/or manufactured using processes including such diploid-cell types, despite the under-documented aspects of the original tissue procurement and of donor consent (Table 4) [6,69,70]. This aspect, along with the specified need for insurance of the utmost material safety and quality, have led to the progressive implementation of many industrial guidelines and requirements aiming to establish best practices, which essentially focus on multifactorial risk reduction [71][72][73][74][75][76][77][78][79][80][81][82][83][84][85].…”

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confidence: 99%

Biotechnology and Cytotherapeutics: The Swiss Progenitor-Cell Transplantation Program

et al. 2022

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Historically, primary human progenitor cells (e.g., WI-38 and MRC-5 diploid-cell sources) have been industrially applied in research and in manufacturing processes for vaccines and for biologicals. Furthermore, tissue-specific primary progenitor-cell banks have recently been developed and exploited for the provision of safe, consistent, and effective cellular active pharmaceutical ingredients (API) in homologous allogeneic regenerative medicine applications. Notably, the modern legal and regulatory frameworks for novel therapeutic products and for progenitor-cell therapy development have been iteratively optimized to guarantee utmost product safety, quality, and efficacy. Over 50 years of global technical hindsight around progenitor-cell biotechnological substrates and over 30 years of in-house clinical experience around the therapeutic uses of standardized progenitor-cell sources in Switzerland have demonstrated the importance of such biological materials for public health. The aim of this entry work was to summarize the evolution of the industrial applications of selected primary progenitor-cell sources, ranging from the use as robust biotechnological substrates to standardized cellular API manufacture and their clinical uses in highly specialized regenerative medicine.

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Cleanrooms and tissue banking how happy I could be with either GMP or GTP?

Cited by 5 publications

References 13 publications

Human presence impacts fungal diversity of inflated lunar/Mars analog habitat

Human presence impacts fungal diversity of inflated lunar/Mars analog habitat

Transplantation of cryopreserved human heart valves in Europe: 30 years of banking in Brussels and future perspectives

Biotechnology and Cytotherapeutics: The Swiss Progenitor-Cell Transplantation Program

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