BioNTech (Mfg Services)

Mainz, DE · Marburg, DE
mRNA
24 confirmed programs · 10 sponsors · Last scored 2026-03-15
70.5
Signal Score
○ FDA Inspections ✓ Clinical Trials (24) ○ SEC Filings ○ Press

Quick Facts: BioNTech (Mfg Services)

Signal Score
70.5/100 (as of 2026-03-15)
Quality Compliance
Assessment pending
Headquarters
Mainz, DE · Marburg, DE
Modalities
mRNA
Active CGT 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 CGT manufacturing intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance —
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA InspectionsNo US records on file
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
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
NCT07361510 A Study to Evaluate the Efficacy of Pumitamig Versus... PHASE3 Not Yet Recruiting
NCT07361497 A Study to Evaluate Pumitamig Versus Durvalumab Following... PHASE3 Not Yet Recruiting
NCT07111520 A Clinical Trial to Test if an Investigational Combination... PHASE1/PHASE2 Recruiting
NCT07070232 A Clinical Study to Test if an Investigational Treatment... PHASE1/PHASE2 Recruiting
NCT06953089 DB-1311 in Combination With BNT327 or DB-1305 in... PHASE2 Recruiting
NCT06940804 A Clinical Study Investigating the Therapeutic Effects and... PHASE2 Withdrawn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... PHASE2 Recruiting
NCT06712355 Safety and Efficacy of BNT327, an Investigational Therapy in... PHASE3 Recruiting
NCT06712316 Safety, Efficacy, and Pharmacokinetics of BNT327 in... PHASE2/PHASE3 Recruiting
View all 24 programs →
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
Financial Stability 83.0
Publicly traded — financial transparency
Source: SEC EDGAR, press monitoring
Subsidiary of BioNTech SE
SEC FilingsParent: BioNTech SE
Publicly traded — financial transparency
Capacity 58.0
3 CGT manufacturing sites
Sites: Mainz, Germany, Marburg, Germany, Idar-Oberstein, Germany
Source: SEC EDGAR, press monitoring, company profiles
3 CGT manufacturing sites
3 CGT manufacturing sites

Clinical Activity 24 studies

NCT07361510 A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in... PHASE3 Not Yet Recruiting NCT07361497 A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent... PHASE3 Not Yet 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 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 Mar 20, 2026
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