BioNTech (Mfg Services)
Mainz, DE · Marburg, DE
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
84.9
Signal Score
○ FDA Inspections
✓ Clinical Trials (28)
✓ SEC Filings (76)
○ Press
✓ EMA GMP (8)
○ MHRA GMP
Quick Facts: BioNTech (Mfg Services)
- Signal Score
- 84.9/100 (as of 2026-09-07)
- Quality Compliance
- 100.0/100
- Headquarters
- Mainz, DE · Marburg, DE
- Modalities
- mRNA
- Active Programs
- Data pending
- 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
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 Certificates8 on record
Operations
75.4
Programs
— no verified data
Sponsors— no verified data
ModalitiesmRNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
NCT06892548
A Clinical Study to Investigate the Efficacy and Safety of an...
PHASE1/PHASE2
Recruiting
View all 28 programs →
Source: ClinicalTrials.gov · Retrieved Oct 06, 2026
Financial Stability
88.0
76 SEC filings with industry mentions on record
SEC Filings76 with industry mentions
Capacity
67.0
Profile-based capacity assessment
BioNTech (Mfg Services) 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 Oct 06, 2026
Clinical Activity 28 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
NCT06750185
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy...
PHASE1/PHASE2
Recruiting
NCT06712316
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With...
PHASE2/PHASE3
Recruiting
NCT06616532
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as...
PHASE3
Active Not 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
NCT05844150
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in...
PHASE2
Active Not 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
NCT05879068
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC
PHASE2
Active Not Recruiting
+ 8 more studies
Source: ClinicalTrials.gov · Retrieved Oct 06, 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 Oct 06, 2026
Frequently Asked Questions About BioNTech (Mfg Services)
Does BioNTech (Mfg Services) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 8 EMA GMP certificates for BioNTech (Mfg Services).
How many clinical programs is BioNTech (Mfg Services) linked to?
BioNTech (Mfg Services) is associated with 28 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is BioNTech (Mfg Services)'s CDMO Signal Score?
BioNTech (Mfg Services) has a Signal Score of 85/100, based on quality, operations, financial stability, and capacity data.
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