The critical and time-sensitive manufacturing procedures for cell and gene therapies require a sound strategy for contamination control to help ensure the microbiological safety of the final product and the protection of both patients and manufacturers.
Cell and gene therapy facilities can differ from traditional pharma facilities in several key ways. The rapid turnaround time and streamlined processes often result in a different set of utilities and facility features that can result in special considerations for ensuring a contamination-free environment. ISO 5 aseptic processing areas require the use of sterile items, sterile disinfectants, and sterile sporicides. The facility may not have access to an autoclave to sterilize non-sterile items coming into the graded area.
A cleaning and disinfection program, as part of an overall Contamination Control Strategy (CCS), should be robust and validated, and address the unique challenges within advanced therapy manufacturing including the special considerations often found within these facilities.
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This article was originally published in American Pharmaceutical Review.
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