Rentschler Biopharma
Laupheim, Germany
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-02
79.9
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (4)
✓ EMA GMP (1)
○ MHRA GMP
Quick Facts: Rentschler Biopharma
- Signal Score
- 79.9/100 (as of 2026-04-02)
- Quality Compliance
- 99.3/100
- Headquarters
- Laupheim, Germany
- Modalities
- AAV, 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
Signal Score & Pillar Breakdown
Quality Compliance
99.3
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-01-17)
EMA GMP Certificates1 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, 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
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
66.0
Active facility expansion (4 articles)
Sites: Laupheim, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press4 articles
Active facility expansion (4 articles)
FDA Inspection History
2025-01
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-01-17 | Milford, Massachusetts | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Apr 05, 2026
EMA GMP Compliance 1 certificates
2023-05
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2025_0209 | Rentschler Biopharma SE | Germany | 2023-05-05 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Apr 05, 2026
Recent News 4 articles
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - Manufacturing Digital Magazine
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion Manufacturing Digital Magazine
Rentschler Biopharma Advances Milford Site Expansion - Contract Pharma
Rentschler Biopharma Advances Milford Site Expansion Contract Pharma
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion - GlobeNewswire
Together We Build: Rentschler Biopharma celebrates Milford site progress and growth since U.S. expansion GlobeNewswire
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Similar CDMOs
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
Signal Score: 92.2
CAR-T, Cell Therapy, Gene Editing, Plasmid, AAV, Lentiviral
WuXi Biologics
Shanghai, CN · Wuxi, CN
Signal Score: 82.9
CAR-T, Cell Therapy, AAV
Danaher (CGT Portfolio)
Washington, DC
Signal Score: 81.5
Cell Therapy, AAV, mRNA
Takeda
Boston, MA · Zurich, CH
Signal Score: 80.7
AAV, Cell Therapy
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Signal Score: 80.2
CAR-T, Cell Therapy, AAV, Lentiviral