Optimization and scale up of production of the PSMA imaging agent [18F]AlF-P16-093 on a custom automated radiosynthesis platform

EJNMMI Radiopharmacy and Chemistry

Table 1 Results from “¹⁸F-rinse” optimization studies using 80 nmoles AlCl₃·6H₂O with ~ 160 nmoles P16-093

Run	PiBOX	[¹⁸F]AlF²⁺°C/min	Label °C/min	Starting F18 (MBq)	Product F18 (MBq)	RCY %	RCY_qma %	Radiochemical purity %	Reagent LOT* AlCl₃/P16-093
1	1	65/5	65/5	250	100	49	54	97	LQ1/FL1
2	1	65/5	65/5	907	396	54	59	97	LQ1/FL1
3	1	65/5	65/5	873	366	51	57	97	LQ1/FL1
4	1	65/5	65/5	855	355	51	55	97	LQ1/FL1
5	1	65/5	65/5	377	155	51	55	96	LQ1/FL1
6	1	65/5	65/10	659	189	36	38	97	LQ1/FL1
7	1	65/5	65/5	1406	595	52	58	98	LQ1/FL1
8	2	65/5	65/5	115	48	51	55	97	LQ1/FL2
9	2	65/5	65/5	1177	581	61	65	98	FD1/FL2
10	2	65/5	65/5	414	196	58	67	97	FD1/FL2
11	2	65/5	65/5	866	422	60	68	98	FD1/FL2
12	2	65/5	65/5	1302	696	66	72	98	FD1/FA3
13	2	65/5	65/5	295	121	50	54	97	FD1/FA3
14	2	65/5	65/5	929	455	60	66	97	FD1/FA3
15	2	65/5	65/2	995	566	68	76	96	FD1/FA3
16	2	65/5	50/2	648	340	64	67	96	FD1/FA3
17	2	65/5	40/2	733	448	74	79	96	FD1/FA3
18	2	65/5	40/2	770	474	74	80	96	FD2/FA3
19	2	65/5	40/2	703	411	71	76	96	FD2/FA3
20	2	65/5	30/2	733	407	67	72	97	FD2/FA3
21	2	–	40/10	1443	844	72	78	96	FD2/FA3
22	2	–	40/5	1632	821	60	66	97	FD2/FA3
23	2	–	50/10	1258	762	74	81	97	FD2/FA3
24	2	–	50/5	268	152	67	73	96	FD2/FA3
25	2	–	50/10	1258	762	74	79	97	FD2/FA3
26	2	50/5	50/5	1628	770	58	65	97	FD2/FA3
27	2	65/5	35/5	1206	692	71	79	96	FD2/FA3
28	3	65/5	40/2	1443	337	28	30	94	FD2/FA3
29	3	65/5	40/2	1591	836	64	67	96	FD3/FA3
30	3	65/5	40/2	2172	1099	61	65	97	FD3/FA3
31	3	65/5	40/4	477	244	62	66	97	FD3/FA4
32	3	65/5	40/4	429	244	70	75	97	FD3/FA4
33	3	65/5	40/4	755	422	69	74	97	FD3/FA4

*LQ#, liquid AlCl₃·6H₂O batch #; FD#, freeze-dried AlCl₃·6H₂O batch #; FL#, P16-093 stored in solution (2 mg/mL) in freezer batch #; FA#, P16-093 stored as solid (100–200 µg) in freezer batch #. Each batch # is a new series of aliquots from the same stock solution of (AlCl₃·6H₂O) or the same lot of P16-093 bulk material