OmniaBio

Hamilton, ON
AAV Lentiviral CAR-T Cell Therapy
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
79.5
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (2) ○ MHRA GMP

Quick Facts: OmniaBio

Signal Score
79.5/100 (as of 2026-04-29)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
Headquarters
Hamilton, ON
Modalities
AAV, Lentiviral, CAR-T, Cell Therapy
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 OmniaBio

Canada's largest CGT CDMO. Connected to CCRM.

Signal Score & Pillar Breakdown

Quality Compliance 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates2 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral, CAR-T, Cell Therapy
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 63.0
Broad modality coverage (4 modalities)
Sites: Hamilton, ON
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Broad modality coverage (4 modalities)

OmniaBio EMA GMP Compliance 2 certificates

2017-12
2015-02
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
IT-API/98/H/2018 OMNIABIOS S.R.L Italy 2017-12-15 COMPLIANT
IT-API/130/H/2015 OMNIABIOS S.R.L Italy 2015-02-20 COMPLIANT
Source: EMA EudraGMDP · Retrieved Jul 04, 2026

Frequently Asked Questions About OmniaBio

Does OmniaBio hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for OmniaBio.
What is OmniaBio's CDMO Signal Score?
OmniaBio has a Signal Score of 80/100, based on quality, operations, financial stability, and capacity data.
Evaluating OmniaBio for a manufacturing program?
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