Rentschler Biopharma
Laupheim, Germany
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
77.6
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (4)
✓ EMA GMP (2)
○ MHRA GMP
Quick Facts: Rentschler Biopharma
- Signal Score
- 77.6/100 (as of 2026-04-29)
- Quality Compliance
- 98.8/100
- Headquarters
- Laupheim, Germany
- Website
- https://rentschler-biopharma.com
- Modalities
- Monoclonal Antibody, Recombinant Protein
- 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 Rentschler Biopharma
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
98.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-01-17)
EMA GMP Certificates2 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesMonoclonal Antibody, Recombinant Protein
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
58.0
1 manufacturing site: Laupheim, DE
Modalities: Monoclonal Antibody, Recombinant Protein
Capacity assessment: 58.0/100
Sites: Laupheim, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press4 articles
1 manufacturing site: Laupheim, DE
Modalities: Monoclonal Antibody, Recombinant Protein
Capacity assessment: 58.0/100
Rentschler Biopharma 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 Jul 04, 2026
Rentschler Biopharma EMA GMP Compliance 2 certificates
2026-02
2023-05
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_BW_01_GMP_2026_0092 | Rentschler Biopharma SE | Germany | 2026-02-05 | COMPLIANT |
| DE_BW_01_GMP_2025_0209 | Rentschler Biopharma SE | Germany | 2023-05-05 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 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
Frequently Asked Questions About Rentschler Biopharma
How many FDA inspections does Rentschler Biopharma have on record?
CDMO Signal tracks 1 FDA inspection for Rentschler Biopharma, sourced from the FDA inspection database. See the full inspection history above.
Has Rentschler Biopharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Rentschler Biopharma.
Does Rentschler Biopharma hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for Rentschler Biopharma.
What is Rentschler Biopharma's CDMO Signal Score?
Rentschler Biopharma has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
Evaluating Rentschler Biopharma for a manufacturing program?
Use the free AI matchmaker to compare Rentschler Biopharma against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Similar CDMOs
Boehringer Ingelheim BioXcellence
Ingelheim am Rhein, Germany
Monoclonal Antibody, Bispecific Antibody, Recombinant Protein, Antibody Fragments, Biosimilars, Biologics
KBI Biopharma
Durham, NC · Boulder, CO
Signal Score: 83.5
Monoclonal Antibody, Recombinant Protein, AAV, Plasmid DNA
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Signal Score: 80.6
CAR-T, Cell Therapy, AAV, Lentiviral, ADC, Monoclonal Antibody, Recombinant Protein
Lonza
Basel, Switzerland
Signal Score: 78.2
AAV, Lentiviral, Cell Therapy, mRNA, ADC, Monoclonal Antibody, Recombinant Protein
Catalent
Bagsværd, Denmark (operating under Novo Holdings)
Signal Score: 76.5
Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish