Wacker Biotech

Jena, DE · Amsterdam, NL · San Diego, CA
Recombinant Protein Plasmid DNA mRNA
No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07
81.6
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (13) ○ MHRA GMP

Quick Facts: Wacker Biotech

Signal Score
81.6/100 (as of 2026-09-07)
Quality Compliance
100.0/100
Headquarters
Jena, DE · Amsterdam, NL · San Diego, CA
Website
Modalities
Recombinant Protein, Plasmid DNA, 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 Wacker Biotech

CureVac mRNA manufacturing partner.

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 Certificates13 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesRecombinant Protein, Plasmid DNA, mRNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 63.0
Profile-based capacity assessment

Wacker Biotech EMA GMP Compliance 13 certificates

2025-11
2025-11
2025-11
2025-11
2025-11
2025-11
2025-06
2025-01
2025-01
2025-01
2024-09
2024-09
2024-09
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_SN_01_GMP_2025_0064 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_SN_01_GMP_2025_0066 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_SN_01_GMP_2025_0063 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_SN_01_GMP_2025_0062 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_SN_01_GMP_2025_0067 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_SN_01_GMP_2025_0065 Wacker Chemie AG Germany 2025-11-04 COMPLIANT
DE_TH_01H_GMP_2025_0038 Wacker Biotech GmbH Germany 2025-06-05 COMPLIANT
NL/API 25/2054513 Wacker Biotech B.V. Netherlands 2025-01-16 COMPLIANT
NL/H 25/2054513B2 Wacker Biotech B.V. Netherlands 2025-01-16 COMPLIANT
NL/H 25/2054513 Wacker Biotech B.V. Netherlands 2025-01-16 COMPLIANT
DE_ST_01_GMP_2025_0017 Wacker Biotech GmbH Germany 2024-09-18 COMPLIANT
DE_ST_01_GMP_2025_0018 Wacker Biotech GmbH Germany 2024-09-18 COMPLIANT
DE_ST_01_GMP_2025_0019 Wacker Biotech GmbH Germany 2024-09-18 COMPLIANT
Source: EMA EudraGMDP · Retrieved Oct 06, 2026

Frequently Asked Questions About Wacker Biotech

Does Wacker Biotech hold EMA or MHRA GMP certificates?
CDMO Signal tracks 13 EMA GMP certificates for Wacker Biotech.
What is Wacker Biotech's CDMO Signal Score?
Wacker Biotech has a Signal Score of 82/100, based on quality, operations, financial stability, and capacity data.
Evaluating Wacker Biotech for a manufacturing program?
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