کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2172447 1093543 2007 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیولوژی سلول
پیش نمایش صفحه اول مقاله
Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use
چکیده انگلیسی

BackgroundCell populations manufactured by conventional commercial cell sorters have been safely infused into patients, but reliably sterilizing these instruments remains challenging. We are developing clinical protocols involving use of ALDH bright cells manufactured by cell sorting in patients. However, we encountered problems when we attempted to reliably sterilize the FACSAria® cell sorter using standard methods.ResultsWe have identified and modified potential sources of microbial contamination in several FACSAria systems. We added new filter systems to the sheath and sample air lines, to the wet cart fluid supply, and to the sample line. Sheath was provided from an external sterile, disposable bag through sterile disposable tubing sets. The plenum reservoirs were modified in several ways to allow efficient decontamination of internal surfaces. A new bubble filter assembly was added and one valve was eliminated from the sample pathway to improve flow cell sterilization. A new cleaning and sterilization protocol was developed and validated. All cell products manufactured using the modified instrument and validated cleaning protocol have met lot release criteria for prevention of microbial contamination and safe clinical use.DiscussionThe instrument modification and cleaning protocol described enable reliable manufacture of ALDH bright cell populations that are suitable for clinical trials. We have manufactured nineteen consecutive samples that meet all clinical release criteria in an on-going Phase 1 human trial.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Cytotherapy - Volume 9, Issue 6, 2007, Pages 562–568
نویسندگان
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