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8 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2024 PharmTech.com Biologics TABLE II. Assessment of the method sensitivity. 10 colony forming unit (CFU) inoculation in triplicate in one batch of chimeric antigen receptor (CAR)‐T product. Time to detection is recorded for BD Bacterial Automated Detection and Enumeration (BACTEC) FX40. *The compendial samples were evaluated only on working days. The positivity could have been detected one/two days earlier. Tested sample Microorganism 10 CFU BACTEC FX40 Direct inoculation CAR-T-1 Clostridium sporogenes 16 h 8 min 1 day CAR-T-2 17 h 36 min 1 day CAR-T-3 16 h 4 min 1 day Positive control 15 h 33 min 1 day CAR-T-1 Cutibacterium acnes 3 days 20 h 11 min 6 days * CAR-T-2 3 days 12 h 6 min 6 days * CAR-T-3 3 days 23 h 8 min 6 days * Positive control 3 days 15 h 41 min 6 days * CAR-T-1 Staphylococcus aureus 16 h 4 min 2 days CAR-T-2 16 h 5 min 2 days CAR-T-3 15 h 38 min 2 days Positive control 15 h 7 min no growth CAR-T-1 Streptococcus pyogenes 10 h 19 min 3 days * CAR-T-2 10 h 25 min 3 days * CAR-T-3 10 h 39 min 3 days * Positive control 12 h 57 min 3 days * CAR-T-1 Brachybacterium nesterenkovii 1 day 11 h 34 min 3 days * CAR-T-2 1 day 10 h 4 min 3 days * CAR-T-3 1 day 11 h 38 min 3 days * Positive control 1 day 9 h 40 min 3 days * CAR-T-1 Pseudomonas aeruginosa 15 h 24 min no growth CAR-T-2 17 h 34 min no growth CAR-T-3 18 h 36 min no growth Positive control 17 h 38 min no growth CAR-T-1 Bacillus subtilis 13 h 3 min 2 days CAR-T-2 12 h 53 min 2 days CAR-T-3 12 h 36 min 2 days Positive control 12 h 18 min 2 days CAR-T-1 Candida albicans 1 day 1 h 8 min 2 days CAR-T-2 1 day 9 h 36 min 2 days CAR-T-3 1 day 7 h 31 min 2 days Positive control 1 day 7 h 42 min 2 days CAR-T-1 Aspergillus brasiliensis 3 days 5 h 43 min 3 days CAR-T-2 3 days 11 h 27 min 3 days CAR-T-3 3 days 20 h 6 min 3 days Positive control 2 days 23 h 10 min 3 days