Wacker Biotech

Jena, DE · Amsterdam, NL · San Diego, CA
Recombinant Protein Plasmid DNA mRNA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
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 2026-04-29)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
Headquarters
Jena, DE · Amsterdam, NL · San Diego, CA
Website
Modalities
Recombinant Protein, Plasmid DNA, mRNA
Active Programs
No ClinicalTrials.gov matches confirmed
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

Quality Compliance 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates13 on record
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 — no verified data
Sponsors— no verified data
ModalitiesRecombinant Protein, Plasmid DNA, mRNA
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Parent company: Wacker Chemie AG (WCH.DE)
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Wacker Chemie AG (WCH.DE)
Financial assessment: 68.0/100
Capacity 63.0
3 manufacturing sites
Sites: Jena, Germany, Amsterdam, Netherlands, San Diego, CA
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
3 manufacturing sites

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 Jul 04, 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?
Use the free AI matchmaker to compare Wacker Biotech against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Recombinant Protein CDMOs → Plasmid DNA CDMOs → mRNA CDMOs →

Similar CDMOs

Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
Signal Score: 75.1
Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
Catalent
Bagsværd, Denmark (operating under Novo Holdings)
Signal Score: 76.5
Monoclonal Antibody, Recombinant Protein, ADC, AAV, mRNA, Plasmid DNA, Fill-Finish
KBI Biopharma
Durham, NC · Boulder, CO
Signal Score: 83.5
Monoclonal Antibody, Recombinant Protein, AAV, Plasmid DNA
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
Signal Score: 72.8
AAV, Lentiviral, Cell Therapy, mRNA, Monoclonal Antibody, Recombinant Protein
Bionova Scientific
Fremont, CA
Signal Score: 59.0
Monoclonal Antibody, Recombinant Protein, Plasmid DNA