Table 2.

Buffer formulation screening based on lyophilized cake optical appearance after 30 days post lyophilization in glass vials.

	Acceptable cake appearance
	No excipient						1 % trehalose						2 % trehalose						1 % sucrose						2 % sucrose
	-80°C			RT			-80°C			RT			-80°C			RT			-80°C			RT			-80°C			RT
0.1 M sodium phosphate pH 7.4																			+	+	+	–	–	+
0.01 M sodium phosphate pH 7.4							+	+	+	x	x	x	+	+	+	+	+	+	+	+	+	–	–	–	+	+	+	-	-	-
0.1 M sodium phosphate pH 7.8	+	+	+	+	+	+	+	+	+	–	–	–	+	+	+	+	–	–							+	+	+	-	-	+
0.01 M sodium phosphate pH 7.8							+	+	+	x	–	x	+	+	+	+	+	+	+	+	+	–	–	–	+	+	+	-	-	-

Formed or formed but shrunken cakes are assigned a “+” or an “x” when difficult to reconstitute, not-formed or collapsed cakes receive a “-”. Six values per formulation are resultant from three lyophilized products each stored at - 80°C and RT.