Biovian

Turku, Finland
AAV Lentiviral
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
77.6
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (4) ○ MHRA GMP

Quick Facts: Biovian

Signal Score
77.6/100 (as of 2026-04-29)
Quality Compliance
98.8/100
Headquarters
Turku, Finland
Modalities
AAV, Lentiviral
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 Biovian

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 98.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2024-12-19)
EMA GMP Certificates4 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral
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 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 58.0
1 manufacturing site: Turku, FI
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100
Sites: Turku, FI
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Turku, FI
Modalities: AAV, Lentiviral
Capacity assessment: 58.0/100

Biovian FDA Inspection History

2024-12
NAI VAI OAI
Date Site Type Observations Classification
2024-12-19 Turku Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Biovian EMA GMP Compliance 4 certificates

2026-03
2024-12
2024-12
2024-12
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
FIMEA/2026/001005 laboratory Biovian Oy Finland 2026-03-18 COMPLIANT
FIMEA/2024/006346 laboratory Biovian Oy Finland 2024-12-19 COMPLIANT
FIMEA/2024/006346 IMP Biovian Oy Finland 2024-12-19 COMPLIANT
FIMEA/2024/006346 Biovian Oy Finland 2024-12-19 COMPLIANT
Source: EMA EudraGMDP · Retrieved Jul 04, 2026

Frequently Asked Questions About Biovian

How many FDA inspections does Biovian have on record?
CDMO Signal tracks 1 FDA inspection for Biovian, sourced from the FDA inspection database. See the full inspection history above.
Has Biovian received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Biovian.
Does Biovian hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for Biovian.
What is Biovian's CDMO Signal Score?
Biovian has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
Evaluating Biovian for a manufacturing program?
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