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Table 3 Predefined and final specification for the starting material

From: Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Pre-acceptance controls Pre-defined specification Validation run Final specification
#01 #02 #03 #04
Accompanying documents Present Present (4/4 batches) C
Bag identificative Anonym, univocal code Anonym, univocal code (4/4 batches) C
Volume harvested To be set 58 mL 71 mL 54 mL 58 mL ≥ 50 mL
Transportation mean temperature [range] To be set (transport at controlled temperature in refrigerated container with ice packs and validated data logger) Not available 0.4 °C [− 3.9–13.1] 5.3 °C [4.0–24.6] 3.1 °C [2.2–6.7] 2–8 °C
Time from harvesting Up to 12 h from the completion of collection to receipt at the manipulation site 06h53 03h59 04h51 04h08 ≤ 12 h
State of the collection bag Intact and appropriately sealed Intact and appropriately sealed (4/4 batches) C
BacT/ALERT aerobic Sterile Sterile (4/4 batches) C
BacT/ALERT anaerobic Sterile Sterile (4/4 batches) C
  1. C compliant with predefined specifications