Merck KGaA / MilliporeSigma (CDMO)

Darmstadt, DE · St. Louis, MO

Profile last updated: 2026-03-31

Hybrid — also manufactures internal programs

mRNA Biologics Cell Therapy

No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07

81.8

Signal Score

✓ FDA Inspections (2) ✓ Clinical Trials (22) ○ SEC Filings ○ Press ✓ EMA GMP (2) ○ MHRA GMP

Quick Facts: Merck KGaA / MilliporeSigma (CDMO)

Signal Score: 81.8/100 (as of 2026-09-07)
Quality Compliance: 98.7/100
Headquarters: Darmstadt, DE · St. Louis, MO
Modalities: mRNA, Biologics, Cell Therapy
Active Programs: Data pending
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

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

FDA Inspections2 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-04-28)

EMA GMP Certificates2 on record

Operations

Programs — no verified data

Sponsors— no verified data

ModalitiesmRNA, Biologics, Cell Therapy

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

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 Oct 06, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Profile-based capacity assessment

Merck KGaA / MilliporeSigma (CDMO) FDA Inspection History

2025-04

2025-03

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-04-28	Sigma-Aldrich Manufacturing LLC Saint Louis, Missouri Facility-linked	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)
2025-03-14	Merck Life Science Technologies (Nantong) Co., Ltd. Nantong Facility-linked	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved Oct 06, 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 Oct 06, 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 Oct 06, 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 82/100, based on quality, operations, financial stability, and capacity data.

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