Flyer
Gene Therapy
Gene Therapy
6-8 weeks clinical manufacturing from plasmid to AAV
AAV Vector Production - Triple Transient Transfection System
TM
AAssistVTM-
AAssistV
pRC
-
pHelper
GOI
Transfer
Packaging Cell Line
AAV Vector
(Proprietary AAV Cell Line PowerSTM-293)
Plasmid
Ready to used
Ready to used
Proprietary PowerSTM-ITRrs
strain, other commercial
strains available
Proprietary PowerSTM-293
AAssistVTM-pHelper
plasmid with FDA
DMF registration
(MF29497)
AAssistVTM-pRC
plasmid with FDA
DMF registration
(MF29497)
suspension cell line with
FDA DMF registration
(MF29801)
A Global One-stop shop multi-modality CDMO partner with
solid service delivery experience and leading value proposition
Phase
I
Phase
II
Phase
III
IND
BLA
Plasmid
AAV
Pre
C
M
C
G
rade
IND CMC
IND CMC
GMP-Principle* Grade
Clinical GMP Grade
GMP Grade
GMP Grade
BLA PC/PV
BLA PC/PV
GMP Grade
GMP Grade
P
r
o
G
r
ad
e
*2 choices in GMP-principle grade: IND Pro for FDA & EMA; GMProTM for NMPA(China), FDA & EMA
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
PowerSTM-ITRrs Strain for Transfer Plasmid:
Lower Recombination Rate with Higher Yield
Lower ITR Recombination Rate in P10
Higher Fermentation Yield
PowerS-ITRrs
Stbl3
Vendor’s strain
PowerS-ITRrs
Stbl3
Vendor’s strain
Proprietary Cell Line PowerSTM-293 for AAV Manufacturing
2.0×1014
1.5×1014
Robust and scalable manufacturing process
for different serotypes, up to 200L
1.0×1014
Titer ≥ 1E14 vg/L, similar yield as Benchmark
5.0×1013
0