Investor Presentaiton
Testing Poses Complexity and Challenges to the CGT Industry
·
Testing evolution from
Small Molecules to
Advanced Therapies
B
Vaccine
COVID.19
•
Testing Platforms for CAR-T Products
Product specific release tests:
CAR Expression by Flow Cytometry
Integrated Copy Number (GOI specific)
General characteristics:
•
Cell Count and Viability by NC-200
Additional Capabilities (as needed):
.
Potency Assays (product specific)
.
.
T-cell Memory Phenotype by Flow Cytometry
T-Cell Activation by Flow Cytometry
T-Cell Exhaustion by Flow Cytometry
XXXXX
.
Small Molecule Testing
•
Simple chemical/physical characterization
Conventional instruments in traditional QC
labs
•
•
In Vitro and PCR based adventitious agents
Residual Viral DNA
1e3
-Cellular Events
:63.24%-#:..
CD4+CD8-
50.41%-#
CD4+CD8+
2.89%-#
1000-
750
1e2
•
Identity by Flow Cytometry
•
Cellular Impurities by Flow Cytometry
Safety Testing:
1000
•
Sterility, Endotoxin, Mycoplasma
•
Replication Competent Virus
500
250
.
750-
CD4+ CAR+
57.31%-#
1e1
CD4-C
40.55%
500-
CD4-CD8-
6.15%-#
250
0
0
250 500 750 1000
-101
1e1
1e2
1e3
-1 0 1
1e1
1e2 1e3
Advanced Therapy Testing
•
•
Complex biologics, viral and cell characterization
Advanced instrumentation in development labs
Broadly used cell based assays (potency assays)
? Wuxi AppTec
药明康德View entire presentation