Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
82.2
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (2)
✓ EMA GMP (2)
✓ MHRA GMP (4)
Quick Facts: Minaris Advanced Therapies
- Signal Score
- 82.2/100 (as of 2026-04-29)
- Quality Compliance
- 97.2/100
- Headquarters
- Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
- Modalities
- CAR-T, Cell Therapy
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Minaris Advanced Therapies
Merged WuXi AT + PCT/Hitachi. Acquired by Altaris from WuXi AppTec (2024).
Signal Score & Pillar Breakdown
Quality Compliance
97.2
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-09-29)
EMA GMP Certificates2 on record
MHRA GMP Certificates4 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Parent company: Altaris Capital Partners
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Altaris Capital Partners
Financial assessment: 68.0/100
Capacity
70.0
Multi-site operations (4 manufacturing sites)
Sites: Philadelphia, PA, Allendale, NJ, Yokohama, Japan, Munich, Germany
Source: SEC EDGAR, press monitoring, company profiles
4 manufacturing sites
StatusLimited
Multi-site operations (4 manufacturing sites)
Sites: Philadelphia, PA, Allendale, NJ, Yokohama, Japan, Munich, Germany
Recent Press2 articles
Multi-site operations (4 manufacturing sites)
Minaris Advanced Therapies FDA Inspection History
2025-09
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-29 | Allendale, New Jersey | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Minaris Advanced Therapies EMA GMP Compliance 2 certificates
2025-07
2024-02
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BY_04_GMP_2026_0001 | MINARIS Regenerative Medicine GmbH | Germany | 2025-07-30 | COMPLIANT |
| DE_BY_04_GMP_2026_0002 | MINARIS Regenerative Medicine GmbH | Germany | 2024-02-08 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 2026
Minaris Advanced Therapies MHRA GMP Compliance 4 certificates
2017-03
2009-04
2009-04
2009-04
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 35210 Insp GMP 35210/978451-0004[H] | WUXI APPTEC INCORPORATED | 30066 | 2017-03-02 | COMPLIANT |
| UK GMP 35210 Insp GMP 35210/935445-0001 [H] | WUXI APPTEC INCORPORATED | 19112 | 2009-04-30 | COMPLIANT |
| UK GMP 35210 Insp GMP 35210/935445-0001 [V] | WUXI APPTEC INCORPORATED | 19112 | 2009-04-30 | COMPLIANT |
| UK GMP 35210 Insp GMP 35210/940604-0001[H] | WUXI APPTEC INCORPORATED | 55120 | 2009-04-27 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Jul 04, 2026
Recent News 2 articles
Minaris Advanced Therapies launches new manufacturing facility in Munich - MSN
Minaris Advanced Therapies launches new manufacturing facility in Munich MSN
Minaris Unveils GMP-Grade NGS to Redefine Viral Safety Testing for Biologics and Advanced Therapies - BioBuzz
Minaris Unveils GMP-Grade NGS to Redefine Viral Safety Testing for Biologics and Advanced Therapies news.biobuzz.io
Frequently Asked Questions About Minaris Advanced Therapies
How many FDA inspections does Minaris Advanced Therapies have on record?
CDMO Signal tracks 1 FDA inspection for Minaris Advanced Therapies, sourced from the FDA inspection database. See the full inspection history above.
Has Minaris Advanced Therapies received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Minaris Advanced Therapies.
Does Minaris Advanced Therapies hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA and 4 MHRA GMP certificates for Minaris Advanced Therapies.
What is Minaris Advanced Therapies's CDMO Signal Score?
Minaris Advanced Therapies has a Signal Score of 82/100, based on quality, operations, financial stability, and capacity data.
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