Moderna (Contract Mfg)
Norwood, MA
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
81.8
Signal Score
✓ FDA Inspections (2)
✓ Clinical Trials (10)
✓ SEC Filings (15)
○ Press
✓ EMA GMP (4)
○ MHRA GMP
Quick Facts: Moderna (Contract Mfg)
- Signal Score
- 81.8/100 (as of 2026-09-07)
- Quality Compliance
- 100.0/100
- Headquarters
- Norwood, MA
- Modalities
- 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 Moderna (Contract Mfg)
mRNA technology leader with internal manufacturing.
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 Inspections2 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-11-21)
EMA GMP Certificates4 on record
Operations
63.0
Programs
— no verified data
Sponsors— no verified data
ModalitiesmRNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
NCT06305767
A Clinical Study of Intismeran Autogene (V940) Treatment and...
PHASE1/PHASE2
Active Not Recruiting
NCT05533697
Study of mRNA-4359 Administered Alone and in Combination With...
PHASE1/PHASE2
Recruiting
Source: ClinicalTrials.gov · Retrieved Oct 06, 2026
Financial Stability
89.0
15 SEC filings with industry mentions on record
SEC Filings15 with industry mentions
Capacity
66.0
Profile-based capacity assessment
Moderna (Contract Mfg) FDA Inspection History
2025-11
2025-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-21 |
Moderna Biotech Spain S.L.
Madrid
Facility-linked
|
Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
| 2025-03-11 |
Moderna US Inc.
Cambridge, Massachusetts
Facility-linked
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 06, 2026
Moderna (Contract Mfg) EMA GMP Compliance 4 certificates
2026-06
2024-06
2023-07
2021-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| ES/091HVI/26 | Moderna Biotech Spain S.L. | Spain | 2026-06-04 | COMPLIANT |
| ES/096HVI/24 | Moderna Biotech Spain S.L. | Spain | 2024-06-20 | COMPLIANT |
| ES/146HVI/23 | Moderna Biotech Spain S.L. | Spain | 2023-07-26 | COMPLIANT |
| ES/175HVI/21 | Moderna Biotech Spain S.L. | Spain | 2021-11-03 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 06, 2026
Clinical Activity 10 studies
NCT07221474
A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and...
PHASE2
Recruiting
NCT06946225
ACTengine® IMA203 Combined With mRNA-4203
PHASE1
Recruiting
NCT06623422
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene...
PHASE3
Recruiting
NCT06295809
A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in...
PHASE2/PHASE3
Terminated
NCT06307431
A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal...
PHASE2
Active Not Recruiting
NCT06305767
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab...
PHASE1/PHASE2
Active Not Recruiting
NCT06077760
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus...
PHASE3
Recruiting
NCT05533697
Study of mRNA-4359 Administered Alone and in Combination With Immune...
PHASE1/PHASE2
Recruiting
NCT04805125
Immunocompromised Swiss Cohorts Based Trial Platform
PHASE3
Completed
NCT03948763
A Study of mRNA-5671/V941 as Monotherapy and in Combination With...
PHASE1
Terminated
Source: ClinicalTrials.gov · Retrieved Oct 06, 2026
Financial Intelligence
"(3)
These assets are related to contract manufacturing service agreements."
"Excluding these expenses, cost of sales and cost of sales as a percentage of net product sales and stand-ready manufacturing revenue decreased by 14% and 72 percentage points, respectively, compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs, losses on firm purchase commitments and inventory write-downs, partially offset by higher sales volume."
"Interest expense is primarily related to our finance leases related to certain contract manufacturing service agreements and, beginning in November 2025, interest associated with our long-term debt."
"Cell therapy enhancer (mRNA-4203 and Anzu-cel (IMA203))
mRNA-4203 is a cell therapy enhancer that encodes for the target of an ex-vivo cell therapy to enhance the persistence and efficacy of the cell therapy."
"At the commercial stage, we manufacture drug substance
and drug product in collaboration with our contract manufacturing organizations (CMOs), both in the United States and internationally."
"In the second quarter of 2023, we acquired a biomanufacturing facility in Marlborough, Massachusetts."
"(3)
These assets are related to contract manufacturing service agreements."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"(3)
These assets are related to contract manufacturing service agreements."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"(3)
These assets are related to contract manufacturing service agreements."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"At the commercial stage, we manufacture drug substance and drug product in collaboration with our contract manufacturing organizations (CMOs), both in the United States and internationally."
"In the second quarter of 2023, we acquired a newly constructed,
140,000
square feet biomanufacturing facility in Marlborough, Massachusetts."
"From time to time, we also partner with and invest in companies developing other types of therapeutics, such as gene editing and cell-therapy, where we believe we can leverage our core mRNA and LNP capabilities to expand the reach of our technology."
"(3)
These assets are real estate assets related to the MTC leases and contract manufacturing service agreements."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"As of June 30, 2024, we had cancelable open purchase orders of $
3.1
billion in total under such agreements for our significant clinical operations and support and contract manufacturing."
"Purchase Commitments and Purchase Orders
We enter into agreements in the normal course of business with vendors and contract manufacturing organizations for raw materials and manufacturing services and with vendors for preclinical research studies, clinical trials and other goods or services."
"In addition to purchase commitments, we have agreements with third parties for various goods and services, including services related to clinical operations and support and contract manufacturing, for which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors."
"As of March 31, 2024, we had cancelable open purchase orders of $
2.6
billion in total under such agreements for our significant clinical operations and support and contract manufacturing."
Source: SEC EDGAR · Retrieved Oct 06, 2026
Frequently Asked Questions About Moderna (Contract Mfg)
How many FDA inspections does Moderna (Contract Mfg) have on record?
CDMO Signal tracks 2 FDA inspections for Moderna (Contract Mfg), sourced from the FDA inspection database. See the full inspection history above.
Has Moderna (Contract Mfg) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Moderna (Contract Mfg).
Does Moderna (Contract Mfg) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Moderna (Contract Mfg).
How many clinical programs is Moderna (Contract Mfg) linked to?
Moderna (Contract Mfg) is associated with 10 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Moderna (Contract Mfg)'s CDMO Signal Score?
Moderna (Contract Mfg) has a Signal Score of 82/100, based on quality, operations, financial stability, and capacity data.
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