MassBiologics

Boston, MA
AAV mRNA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
78.8
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: MassBiologics

Signal Score
78.8/100 (as of 2026-04-29)
Quality Compliance
96.9/100
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 96.9
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

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 May 20, 2026

FDA 483 Findings 1 observations · 2025-12-18 → 2025-12-18 ?

By subsystem

  • CAPA 1 (100.0%)

By severity

  • 3 — Moderate: 1
  • Repeat observations: 0

Most severe findings

  • Moderate (3) CAPA 2025-12-18 21 CFR 211.180(e)(2)
    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."

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