SCTbio
Prague, Czech Republic
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
81.6
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (5)
○ MHRA GMP
Quick Facts: SCTbio
- Signal Score
- 81.6/100 (as of 2026-09-07)
- Quality Compliance
- 100.0/100
- Headquarters
- Prague, Czech Republic
- Modalities
- CAR-T, Cell Therapy
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About SCTbio
Pure-play cell therapy CDMO. Part of PPF Biotech network.
Signal Score & Pillar Breakdown
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
100.0
FDA InspectionsNo US records on file
EMA GMP Certificates5 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
63.0
Profile-based capacity assessment
SCTbio EMA GMP Compliance 5 certificates
2026-03
2026-03
2024-01
2023-11
2022-07
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| sukls420762/2025 | SCT Cell Manufacturing s.r.o. | Czechia | 2026-03-19 | COMPLIANT |
| sukls420756/2025 | SCT Cell Manufacturing s.r.o. | Czechia | 2026-03-18 | COMPLIANT |
| sukls261199/2023 | SCT Cell Manufacturing s.r.o. | Czechia | 2024-01-15 | COMPLIANT |
| sukls261141/2023 | SCT Cell Manufacturing s.r.o. | Czechia | 2023-11-30 | COMPLIANT |
| sukls139841/2022 | SCT Cell Manufacturing s.r.o. | Czechia | 2022-07-14 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 06, 2026
Frequently Asked Questions About SCTbio
Does SCTbio hold EMA or MHRA GMP certificates?
CDMO Signal tracks 5 EMA GMP certificates for SCTbio.
What is SCTbio's CDMO Signal Score?
SCTbio has a Signal Score of 82/100, based on quality, operations, financial stability, and capacity data.
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