Biovian

Turku, FI

AAV Lentiviral

Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02

78.0

Signal Score

✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (3) ○ MHRA GMP

Quick Facts: Biovian

Signal Score: 78.0/100 (as of 2026-04-02)
Quality Compliance: 99.7/100
Headquarters: Turku, FI
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

Quality Compliance

FDA Inspections1 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2024-12-19)

EMA GMP Certificates3 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

Profile-based financial assessment

SEC FilingsPrivate company

Private company

Financial assessment: 60.0/100

Capacity

1 manufacturing site

1 manufacturing site: Turku, FI

Modalities: AAV, Lentiviral

Capacity assessment: 58.0/100

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 Apr 05, 2026

2024-12

Compliant Non-Compliant

Certificate	Site	Country	Inspection Date	Status
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