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

Abstract

Introduction: The sterility test for haematopoietic
progenitor cell (HPC) products for clinical use is a
regulatory requirement demanded by current standards and
the main accreditation organisations for cell therapy.
However, there is no guidance on the methodology that
should be adopted, the appropriate sample volume for the
tests, as well as the criteria for validation, which must
demonstrate that the method adopted for microbiological
analysis is reliable. Objective: To standardise the use of
blood culture vials for cell therapy products by
demonstrating the non-inferiority of this alternative method
compared to the traditional method indicated by the
Brazilian pharmacopoeia. Methodology: For this study,
inoculations were carried out for microbiological testing of
CPH, both negative and positive control, were carried out
in: Aerobic culture: paediatric blood culture bottle and
Thioglycolate, Blood Agar and Chocolate Agar culture
media. Anaerobic culture: anaerobic blood culture bottle
and thioglycolate medium. Fungal culture: paediatric blood
culture bottle and Sabouraud culture medium. The degree
of agreement between the results of the tests obtained on the
different media was analysed. Results: All the cultures
carried out concurrently with the routine showed negative
results in all the media analysed, while the cultures intended
for positive control showed perfect agreement between all
the media analysed. Conclusion: Microbiological analyses
on microbiological analyses on blood cultures proved to be
effective and rapid, demonstrating the non-inferiority of this
alternative method compared to traditional methods using
different culture media.