BioNTech (Mfg Services)
Mainz, DE · Marburg, DE
24 confirmed programs
· 10 sponsors
· Last scored 2026-04-29
84.8
Signal Score
○ FDA Inspections
✓ Clinical Trials (24)
✓ SEC Filings (76)
○ Press
✓ EMA GMP (8)
○ MHRA GMP
Quick Facts: BioNTech (Mfg Services)
- Signal Score
- 84.8/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Mainz, DE · Marburg, DE
- Modalities
- mRNA
- Active Programs
- 24 confirmed from ClinicalTrials.gov across 10 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About BioNTech (Mfg Services)
mRNA COVID vaccine manufacturer. Contract mfg capabilities.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates8 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
75.1
24 active programs across 10 sponsors
Modalities: mRNA
17 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
24 active programs across 10 sponsors · Modalities: mRNA · 17 programs in advanced phases (Phase 2/3)
Programs
24
Sponsors10
ModalitiesmRNA
24 active programs across 10 sponsors
Modalities: mRNA
17 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT06892548
A Clinical Study to Investigate the Efficacy and Safety of an...
PHASE1/PHASE2
Recruiting
View all 24 programs →
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Stability
88.0
Publicly traded — financial transparency
Strong industry presence in SEC filings (95 mentions)
Source: SEC EDGAR, press monitoring
76 SEC filings with industry mentions on record
SEC Filings76 with industry mentions
Publicly traded — financial transparency
Strong industry presence in SEC filings (95 mentions)
Capacity
67.0
3 manufacturing sites
3 facility investment mentions in SEC filings
Sites: Mainz, Germany, Marburg, Germany, Idar-Oberstein, Germany
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
3 manufacturing sites
3 facility investment mentions in SEC filings
FDA 483 Findings 16 observations · 2025-09-05 → 2026-02-05 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 14
- Repeat observations: 0
Most severe findings
-
Corrective action procedures not documented
"Corrective action procedures defining the requirements for determining the causes of nonconformities have not been adequately documented."
-
Written procedures - establish; returned dietary supplements
"You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed, when a returned dietary supplement may be salvaged, for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement and quality control personnel to approve a returned dietary supplement for reprocessing."
-
Rework records not maintained
"Records of rework were not adequately maintained."
EMA GMP Compliance 8 certificates
2025-10
2025-10
2025-10
2025-10
2025-10
2025-06
2024-09
2019-09
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_RP_01_GMP_2025_0049 | BioNTech Innovative Manufacturing Services GmbH | Germany | 2025-10-23 | COMPLIANT |
| DE_RP_01_GMP_2026_0018 | BioNTech SE | Germany | 2025-10-01 | COMPLIANT |
| DE_RP_01_GMP_2026_0004 | BioNTech SE | Germany | 2025-10-01 | COMPLIANT |
| DE_RP_01_GMP_2026_0007 | BioNTech Manufacturing GmbH | Germany | 2025-10-01 | COMPLIANT |
| DE_RP_01_GMP_2026_0025 | BioNTech SE | Germany | 2025-10-01 | COMPLIANT |
| DE_RP_01_GMP_2026_0006 | BioNTech Manufacturing GmbH | Germany | 2025-06-17 | COMPLIANT |
| DE_HE_01_GMP_2025_0030 | BioNTech Manufacturing Marburg GmbH | Germany | 2024-09-04 | COMPLIANT |
| DE_RP_01_GMP_2020_0052 | BioNTech Manufacturing GmbH | Germany | 2019-09-11 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 20, 2026
Clinical Activity 24 studies
NCT07361497
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent...
PHASE3
Recruiting
NCT07361510
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in...
PHASE3
Recruiting
NCT07111520
A Clinical Trial to Test if an Investigational Combination Therapy With...
PHASE1/PHASE2
Recruiting
NCT07070232
A Clinical Study to Test if an Investigational Treatment Called BNT326 is...
PHASE1/PHASE2
Recruiting
NCT06953089
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
PHASE2
Recruiting
NCT06940804
A Clinical Study Investigating the Therapeutic Effects and Safety of an...
PHASE2
Withdrawn
NCT06892548
A Clinical Study to Investigate the Efficacy and Safety of an...
PHASE1/PHASE2
Recruiting
NCT06841055
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational...
PHASE2
Recruiting
NCT06712355
Safety and Efficacy of BNT327, an Investigational Therapy in Combination...
PHASE3
Recruiting
NCT06712316
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With...
PHASE2/PHASE3
Recruiting
NCT06449209
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for...
PHASE2
Active Not Recruiting
NCT06046274
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced...
PHASE2
Withdrawn
NCT05914116
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
PHASE1/PHASE2
Recruiting
NCT05557591
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With...
PHASE2
Active Not Recruiting
NCT05438329
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
PHASE1/PHASE2
Active Not Recruiting
NCT05142189
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy...
PHASE1
Recruiting
NCT03219450
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic...
PHASE1
Recruiting
NCT04534205
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic...
PHASE2/PHASE3
Recruiting
NCT04625205
A Clinical Study of the Safety and Activity of the Investigational Cell...
PHASE1
Terminated
NCT03871348
A First-in-Human Dose Escalation and Expansion Study to Evaluate...
PHASE1
Terminated
+ 4 more studies
Source: ClinicalTrials.gov · Retrieved May 20, 2026
Financial Intelligence
"gene therapy, that are perceived as similar to ours; and
–
the FDA or other regulatory authorities may require us to submit additional data, such as long-term toxicology"
"candidates, such as gene editing therapies, show encouraging results, potential trial participants and their"
"such entities, which include locally-based contract manufacturing organizations, or CMOs, and CROs, in the"
"contract manufacturing production capacities that become redundant or unutilized;
•
our expected revenues and net profit related to sales of our COVID-19 vaccine (also referred to as"
"write-downs and cancellations of contract manufacturing orders."
"operations;
•
continue to invest in our immunotherapy platforms to conduct research to identify novel technologies;
•
change our manufacturing capacity or capability;
•
change or add additional suppliers;
•
make changes to our infrastructure in connection with our quality control, quality assurance, legal,"
"Moreover, in support of the Company’s ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patient populations for which product candidates are being developed in the Company’s respective clinical programs."
Source: SEC EDGAR · Retrieved May 20, 2026
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