MassBiologics
Boston, MA
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
78.9
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: MassBiologics
- Signal Score
- 78.9/100 (as of 2026-04-29)
- Quality Compliance
- 97.0/100
- Headquarters
- Boston, MA
- Modalities
- AAV, 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 MassBiologics
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
97.0
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-12-18)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, 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: UMass Chan Medical School
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: UMass Chan Medical School
Financial assessment: 68.0/100
Capacity
58.0
1 manufacturing site: Boston, MA
Modalities: AAV, mRNA
Capacity assessment: 58.0/100
Sites: Boston, MA
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Boston, MA
Modalities: AAV, mRNA
Capacity assessment: 58.0/100
MassBiologics FDA Inspection History
2025-12
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-12-18 | Boston, Massachusetts | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
MassBiologics FDA 483 Findings 1 observations · 2025-12-18 → 2025-12-18 ?
By subsystem
By severity
- 3 — Moderate: 1
- Repeat observations: 0
Most severe findings
-
Items to cover on annual reviews
"Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product."
Frequently Asked Questions About MassBiologics
How many FDA inspections does MassBiologics have on record?
CDMO Signal tracks 1 FDA inspection for MassBiologics, sourced from the FDA inspection database. See the full inspection history above.
Has MassBiologics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for MassBiologics.
What is MassBiologics's CDMO Signal Score?
MassBiologics has a Signal Score of 79/100, based on quality, operations, financial stability, and capacity data.
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