Table 3.

Effect of prolonged storage and elevated temperature on the radiolabeling of cGMP TCMC-trastuzumab with ²⁰³Pb.

Sample	Temp. (°C)	Time Point	Species	Analysis 1		Analysis 2
				Retention (min)	%	Retention (min)	%
Reference	4	0	HMW	13.1	1.3	12.8	1.4
			IgG	15.4	91.2	15.4	88.8
			LMW	19.5	6.7	19.4	9.1
cGMP	4	0	HMW
			IgG	15.7	100	15.8	100
			LMW
cGMP	21	2 weeks	HMW
			IgG	15.8	100	15.8	100
			LMW
cGMP	21	1 month	HMW
			IgG	15.9	100	15.8	100
			LMW
cGMP	21	3 months	HMW
			IgG	16.0	100	15.9	100
			LMW
cGMP	37	2 weeks	HMW
			IgG	15.8	98.0	15.7	98.5
			LMW	22.1	2.0	22.1	1.5
cGMP	37	1 month	HMW
			IgG	15.8	97.7	15.7	98.5
			LMW	22.1	2.3	22.1	1.5
cGMP	37	3 months	HMW
			IgG	15.8	82.1	15.8	83.0
			LMW	19.6	17.0	19.8	14.0