Moderna (Contract Mfg)
Norwood, MA
10 confirmed programs
· 4 sponsors
· Last scored 2026-04-29
81.8
Signal Score
✓ FDA Inspections (2)
✓ Clinical Trials (10)
✓ SEC Filings (15)
○ Press
✓ EMA GMP (3)
○ MHRA GMP
Quick Facts: Moderna (Contract Mfg)
- Signal Score
- 81.8/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100
- Headquarters
- Norwood, MA
- Modalities
- mRNA
- Active Programs
- 10 confirmed from ClinicalTrials.gov across 4 sponsors
- 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
Quality Compliance
100.0
FDA Inspections2 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-11-21)
EMA GMP Certificates3 on record
Operations
63.0
10 active programs across 4 sponsors
Modalities: mRNA
8 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
10 active programs across 4 sponsors · Modalities: mRNA · 8 programs in advanced phases (Phase 2/3)
Programs
10
Sponsors4
ModalitiesmRNA
10 active programs across 4 sponsors
Modalities: mRNA
8 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
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 May 20, 2026
Financial Stability
89.0
Publicly traded — financial transparency
Strong industry presence in SEC filings (131 mentions)
Major facility investment disclosed in SEC filings
Multiple manufacturing risk factors in SEC filings
Source: SEC EDGAR, press monitoring
15 SEC filings with industry mentions on record
SEC Filings15 with industry mentions
Publicly traded — financial transparency
Strong industry presence in SEC filings (131 mentions)
Major facility investment disclosed in SEC filings
Multiple manufacturing risk factors in SEC filings
Capacity
66.0
10 facility investment mentions in SEC filings
Sites: Norwood, MA
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
10 facility investment mentions in SEC filings
FDA Inspection History
2025-11
2025-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-21 | Madrid | Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
| 2025-03-11 | Cambridge, Massachusetts | Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved May 20, 2026
FDA 483 Findings 7 observations · 2025-09-10 → 2026-01-20 ?
By subsystem
By severity
- 4 — Serious: 1
- 3 — Moderate: 1
- 2 — Minor: 5
- Repeat observations: 0
Most severe findings
-
Qualifications of individuals
"You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training."
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
-
Bottles and other containers - bactericidal treatment
"Failure to subject containers used for storing potable water to effective bactericidal treatment as often as may be necessary to prevent the contamination of water."
EMA GMP Compliance 3 certificates
2024-06
2023-07
2021-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 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 May 20, 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 May 20, 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 May 20, 2026
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