. 2017 May 15;31(3):251–261. doi: 10.1007/s40259-017-0222-9

Table 2.

Critical operating parameters for selected manufacturing steps

Step	Caprylic acid fractionation	S/D treatment	Anion-exchange chromatography	20 nm nanofiltration
Small-scale ratio	1/9000^a and 1/14300^b	1/10330	1/7100 or 1/7400	1/4000
Critical operating parameters	Caprylic acid to protein ratio (%)	Concentration of S/D reagents	Re-use resin	Protein load
	Volume of rinse for Supradur 50P filter	Temperature	Column height	Temperature
		Incubation duration		Pressure

S/D solvent/detergent

^aFor precipitation and Supradur 50P filtration

^bFor AKS 5 filtration