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Validation microbiological controls for cell therapy products using standard culture media and blood culture bottles

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Introduction: The sterility test for haematopoieticprogenitor cell (HPC) products for clinical use is aregulatory requirement demanded by current standards andthe main accreditation organisations for cell therapy.However, there is no guidance on the methodology thatshould be adopted, the appropriate...

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Main Authors: Alves, Suiellen Carvalho Reis, Frizzo, Andréa, Aguiari, Alexandra Greco, Bensi, Eliane Picoli Alves, Teixeira, Patricia Cristiane Spirlandelli, Piveta, Cristiane dos Santos Cruz, Martins, Sandra de Andrade Sousa, Pereira, Fabrício Bíscaro, Benites, Bruno Deltreggia
Format: Online
Language:Portuguese
Published: Universidade Estadual de Campinas 2026
Subjects:
Validation
Microbiological Contamination
Bone Marrow Transplantation
Validação
Contaminação Microbiológica
Transplante de medula óssea
Online Access:https://econtents.sbu.unicamp.br/inpec/index.php/saberes/article/view/20427
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Summary:Introduction: The sterility test for haematopoieticprogenitor cell (HPC) products for clinical use is aregulatory requirement demanded by current standards andthe main accreditation organisations for cell therapy.However, there is no guidance on the methodology thatshould be adopted, the appropriate sample volume for thetests, as well as the criteria for validation, which mustdemonstrate that the method adopted for microbiologicalanalysis is reliable. Objective: To standardise the use ofblood culture vials for cell therapy products bydemonstrating the non-inferiority of this alternative methodcompared to the traditional method indicated by theBrazilian pharmacopoeia. Methodology: For this study,inoculations were carried out for microbiological testing ofCPH, both negative and positive control, were carried outin: Aerobic culture: paediatric blood culture bottle andThioglycolate, Blood Agar and Chocolate Agar culturemedia. Anaerobic culture: anaerobic blood culture bottleand thioglycolate medium. Fungal culture: paediatric bloodculture bottle and Sabouraud culture medium. The degreeof agreement between the results of the tests obtained on thedifferent media was analysed. Results: All the culturescarried out concurrently with the routine showed negativeresults in all the media analysed, while the cultures intendedfor positive control showed perfect agreement between allthe media analysed. Conclusion: Microbiological analyseson microbiological analyses on blood cultures proved to beeffective and rapid, demonstrating the non-inferiority of thisalternative method compared to traditional methods usingdifferent culture media.
ISSN:2447-9411

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