Investor Presentaiton
IND Express: Cell Therapy (w/ plasmid and LVV)
Company A
.
IND Express Case in Progress for Investigator Initiated Trial ("IIT") Purpose in China
2*TCRT IIT in 11 Months (from Plasmid to Cell Therapy Product)
• ATU will provide CDMO Services for
Company "SR" 2*TCRT IIT project:
-
2*GOI Plasmid: PCB banking, Demo and Verification
run, ENG (IIT) run
2*GOI LVV: DoE, Demo, 2*Verification, IIT run
2*GOI TCRT: MOI study, Process optimization, APS,
ENG and IIT run
• IND Express Strategy
-
Adopt overlapping execution by risk assessment to
shorten the project line
Fully integrated PD/AD, clinical MFG and QC to enable
IIT batch manufacture and release testing
Incoming
SOW
DoE
V-run
PTP
TT to
MSAT/MFG
TTSR
APS/IIT Runs
PD ownership
PD/MFG/MSAT ownership
Activity
Feb
Mar Apr May Jun
Jul
Aug
Sep Oct
Nov
Dec
Plasmids
TCRT
0 2023-0
GOI ENG/TST
GOI#1 LVV IIT/TST
GOI#2 LVV IIT/TST
23-07-25
GOI#1 TCRT IIT
GOI#2 TCRT IIT
? Wuxi AppTec
药明康德View entire presentation