Time
6 months
12 months
EMT-601 lead candidate
EMT-602
EMT-603
Time
6 months
12 months
EMT-601 lead candidate
EMT-602
EMT-603
Fast Track Development Timeline
11 months CLD to IND filing
Activity
Duration
123456
789101112
Viability Culture (VC)
0.75 mo
Cell line development (w/ transposase)
2.5 mo
Analysis
0.5 mo
MCB Mfg. (Shipment + Conditional Release)
2.5 mo
Process development
4.25 mo
Non-GMP DS (tox.)
1.5 mo
DP (Tox.)
mo 8.5
Analytical method co-qualification
3 mo
Non-GMP DP release
mo 8.5
cGMP DS
1.5 mo
cGMP DP
–
cGMP DS lot release
mo 10
Regulatory documentation
3 mo
cGMP DP lot release
mo 11
CLD to IND filing (< 11 mo)
mo 11
Early Tox. production strategy.
Milestone / lot release
- CLD Cell Line Development
- cGMP Good Manufacturing Process
- MCB Master Cell Bank
- IND Investigational New Drug
- DS Drug Substance
- DP Drug Product
Fast Track Development Timeline
11 months CLD to IND filing
Activity
Duration
1
2
3
4
5
6
7
8
9
10
11
12
Viability Culture (VC)
0.75 mo
Cell line development (w/ transposase)
2.5 mo
Analysis
0.5 mo
MCB Mfg. (Shipment + Conditional Release)
2.5 mo
Process development
4.25 mo
Non-GMP DS (tox.)
1.5 mo
DP (Tox.)
mo 8.5
Analytical method co-qualification
3 mo
Non-GMP DP release
mo 8.5
cGMP DS
1.5 mo
cGMP DP
–
cGMP DS lot release
mo 10
Regulatory documentation
3 mo
cGMP DP lot release
mo 11
CLD to IND filing (< 11 mo)
mo 11
Early Tox. production strategy.
Milestone / lot release
- CLD Cell Line Development
- cGMP Good Manufacturing Process
- MCB Master Cell Bank
- IND Investigational New Drug
- DS Drug Substance
- DP Drug Product