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Human Pancreatic Islet Isolation: Part I: Digestion and Collection of Pancreatic Tissue
Published on: May 26, 2009
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Detection of Microbial Contamination during Human Islet Isolation
Tatsuya Kin1, Shawn Rosichuk1, A M James Shapiro1
1Clinical Islet Transplant Program, University of Alberta and Capital Health Authority, Edmonton, Alberta, Canada.
Cell Transplantation
|September 8, 2017
Summary
Microbial contamination in pancreas transport solutions is common, but islet processing under current good manufacturing practice (cGMP) significantly reduces it. Final islet products rarely show contamination, though de novo contamination can still occur during processing.
Area of Science:
- Transplantation immunology
- Microbiology
- Biotechnology
Background:
- Current good manufacturing practice (cGMP) facilities are crucial for producing clinical-grade islets for transplantation.
- Monitoring microbial contamination is essential for ensuring the safety of islet products.
Purpose of the Study:
- To assess the rate of microbial contamination in islet products following the implementation of cGMP.
- To identify sources and timing of microbial contamination during islet processing.
Main Methods:
- Fluid samples collected from pancreas transport solution, post-decontamination, post-isolation, and final product.
- Bacterial, fungal, and mycoplasma cultures performed over 2-3 weeks.
- Analysis of contamination rates in relation to preservation factors and processing steps.
Main Results:
- 31% of initial pancreas transport solutions were contaminated.
- Pancreas surface decontamination eliminated 92% of detected microbes.
- Six islet preparations showed de novo contamination during isolation.
- Two transplanted islet products later tested positive, with no patient infections.
Conclusions:
- While pancreas transport solutions pose a high contamination risk, cGMP processing effectively reduces microbial load.
- De novo contamination during islet processing remains a challenge even under strict cGMP conditions.
- Final islet products are generally sterile, and post-transplant infections are rare.
