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. 2022 Jan 31;29(1):413–426. doi: 10.1080/10717544.2022.2030429

Table 3.

CQA outcomes for optimization of cryoprotectants levels and FD procedure.

Parameter Critical Quality Attribute (CQA)
Cake appearance Residual moisture (%) Reconstitution Product Reconstitution time (min)
Man: Suc (% w/v) All samples prepared using unannealed FD protocol
 4:1 Granular with large aggregates 11.34±3.63 Significant precipitation N/A
 4:2 Granular with large aggregates 9.81±2.85 Significant precipitation N/A
 6:2 Granular 10.28±2.40 Some precipitation N/A
FD protocol All samples prepared with fixed Man: Suc at 6/2 %w/v
 Unannealed Granular with large aggregates 10.28±2.40 Some precipitation N/A
 Conservative Fine powder 4.47±1.13a Completely soluble 3.28±0.49
 Extensive Fine powder 4.09±0.91b Completely soluble 2.52±0.81

a, b Residual moisture content was lower than that of unannealed FD samples, ρ<.05.