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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