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You mentioned that you have made cryo; did you make single, or pooled or both? Did you use saline in the process? As I understand, saline is not allowed in the pre-pooled manufacture of cryo. Thank you. -
We have recently completed validation for manufacturing pooled cryo, but are struggling with both the expiration time (4 vs. 6 hours) and a recently found regulation that says saline is NOT ALLOWED in the manufacture of pooled cryo. We do not use an SCD to manufacture our pools and 2 of our pooled cryo suppliers use saline in their pool manufacturing process. can anyone enlighten us? Thanks!