Merck KGaA / MilliporeSigma (CDMO)

Darmstadt, DE · St. Louis, MO
Hybrid — also manufactures internal programs
mRNA Biologics Cell Therapy
22 confirmed programs · 11 sponsors · Last scored 2026-04-29
81.3
Signal Score
✓ FDA Inspections (2) ✓ Clinical Trials (22) ○ SEC Filings ○ Press ✓ EMA GMP (2) ○ MHRA GMP

Quick Facts: Merck KGaA / MilliporeSigma (CDMO)

Signal Score
81.3/100 (as of 2026-04-29)
Quality Compliance
97.3/100
Headquarters
Darmstadt, DE · St. Louis, MO
Modalities
mRNA, Biologics, Cell Therapy
Active Programs
22 confirmed from ClinicalTrials.gov across 11 sponsors
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Merck KGaA / MilliporeSigma (CDMO)

Life science tools company with CDMO services.

Signal Score & Pillar Breakdown

Quality Compliance 97.3
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-04-28)
EMA GMP Certificates2 on record
Operations 72.3
22 active programs across 11 sponsors
Modalities: Cell Therapy, mRNA, Biologics
16 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
22 active programs across 11 sponsors · Modalities: Cell Therapy, mRNA, Biologics · 16 programs in advanced phases (Phase 2/3)
Programs 22
Sponsors11
ModalitiesmRNA, Biologics, Cell Therapy
22 active programs across 11 sponsors
Modalities: Cell Therapy, mRNA, Biologics
16 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT06110195 Study of Xevinapant With Radiation and Chemotherapy for... PHASE1 Terminated
NCT04792073 Study of Avelumab and/or Radiation Therapy in People With... PHASE2 Active Not Recruiting
NCT04052204 Avelumab With Bempegaldesleukin With or Without Talazoparib... PHASE1/PHASE2 Terminated
NCT03737721 The UNSCARRed Study: UNresctable Squamous Cell Carcinoma... PHASE2 Terminated
NCT03747419 Avelumab and Radiation in Muscle-Invasive Bladder Cancer PHASE2 Terminated
NCT03409458 A Dose Escalation and Confirmation Study of PT-112 in... PHASE1/PHASE2 Completed
NCT03271372 Adjuvant Avelumab in Merkel Cell Cancer PHASE3 Active Not Recruiting
NCT02968940 Avelumab With Hypofractionated Radiation Therapy in Adults... PHASE2 Completed
NCT02584829 Localized Radiation Therapy or Recombinant Interferon Beta... PHASE1/PHASE2 Terminated
NCT02083679 Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer PHASE1 Terminated
View all 22 programs →
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
Financial Stability 83.0
Publicly traded — financial transparency
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Publicly traded — financial transparency
Capacity 63.0
3 manufacturing sites
Sites: Darmstadt, Germany, St. Louis, MO, Carlsbad, CA
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
3 manufacturing sites

Merck KGaA / MilliporeSigma (CDMO) FDA Inspection History

2025-04
2025-03
NAI VAI OAI
Date Site Type Observations Classification
2025-04-28 Saint Louis, Missouri Drug Quality Assurance No Voluntary Action Indicated (VAI)
2025-03-14 Nantong Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Merck KGaA / MilliporeSigma (CDMO) EMA GMP Compliance 2 certificates

2024-05
2023-10
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_HH_01_GMP_2024_0040 Merck KGaA Germany 2024-05-24 COMPLIANT
DE_HE_01_GMP_2023_0055 Merck KGaA Germany 2023-10-06 COMPLIANT
Source: EMA EudraGMDP · Retrieved Jul 04, 2026

Clinical Activity 22 studies

NCT06110195 Study of Xevinapant With Radiation and Chemotherapy for Patients With Head... PHASE1 Terminated NCT04792073 Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel... PHASE2 Active Not Recruiting NCT04052204 Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide... PHASE1/PHASE2 Terminated NCT03737721 The UNSCARRed Study: UNresctable Squamous Cell Carcinoma Treated With... PHASE2 Terminated NCT03747419 Avelumab and Radiation in Muscle-Invasive Bladder Cancer PHASE2 Terminated NCT03409458 A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors... PHASE1/PHASE2 Completed NCT03271372 Adjuvant Avelumab in Merkel Cell Cancer PHASE3 Active Not Recruiting NCT02968940 Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate... PHASE2 Completed NCT02584829 Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With... PHASE1/PHASE2 Terminated NCT02083679 Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer PHASE1 Terminated NCT01390818 Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally... PHASE1 Completed NCT01040832 EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve... PHASE2 Completed NCT00813943 Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With... PHASE2 Completed NCT00689221 Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With... PHASE3 Completed NCT00633529 Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment... PHASE1 Completed NCT00111839 Effects of Matuzumab in Combination With Pemetrexed for the Treatment of... PHASE2 Completed NCT00132522 EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate,... PHASE1 Completed NCT01077960 Safety and Efficacy Study of Serostim® Human Immunodeficiency... PHASE3 Completed NCT00071240 Growth Hormone to Increase Immune Function in People With HIV PHASE2 Completed NCT00294918 An Efficacy and Safety Trial of Serostim® in the Maintenance of the... PHASE2/PHASE3 Completed
+ 2 more studies
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Frequently Asked Questions About Merck KGaA / MilliporeSigma (CDMO)

How many FDA inspections does Merck KGaA / MilliporeSigma (CDMO) have on record?
CDMO Signal tracks 2 FDA inspections for Merck KGaA / MilliporeSigma (CDMO), sourced from the FDA inspection database. See the full inspection history above.
Has Merck KGaA / MilliporeSigma (CDMO) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Merck KGaA / MilliporeSigma (CDMO).
Does Merck KGaA / MilliporeSigma (CDMO) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for Merck KGaA / MilliporeSigma (CDMO).
How many clinical programs is Merck KGaA / MilliporeSigma (CDMO) linked to?
Merck KGaA / MilliporeSigma (CDMO) is associated with 22 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Merck KGaA / MilliporeSigma (CDMO)'s CDMO Signal Score?
Merck KGaA / MilliporeSigma (CDMO) has a Signal Score of 81/100, based on quality, operations, financial stability, and capacity data.
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