---
name: Cell and Gene Therapy CRO Services | uBriGene
slug: ubrigene
site: cro
website_domain: ubrigene.com
summary: Cell and Gene Therapy CRO Services | uBriGene provides CRO services. Discovery_source:brave. Headquartered in Maryland, United States.
tagline: Your bridge from ATMP concept to commercialization with expert cell and gene therapy CDMO services.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-06-10T01:45:45.348Z
services_count: 5
modalities_count: 4
indications_count: 1
locations_count: 3
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Cell and Gene Therapy CRO Services | uBriGene

Your bridge from ATMP concept to commercialization with expert cell and gene therapy CDMO services.

Listed on cro.directory.

## Summary

Cell and Gene Therapy CRO Services | uBriGene provides CRO services. Discovery_source:brave. Headquartered in Maryland, United States.

## At a glance

- HQ country: US

## Services

- Translational Research
- China NMPA Regulatory Strategy
- EU EMA Regulatory Strategy
- US FDA Regulatory Strategy
- Analytical Method Development & Validation

## Modalities

- AAV / Viral Vector Platform
- mRNA
- Cell Therapy
- Gene Therapy

## Indications

- Oncology

## Locations

- Worcester, Worcester, Massachusetts, USA
- Boston, Boston, Massachusetts, USA
- Headquarters, Maryland, Maryland, USA

## Certifications

- NMPA; Identifier: 20+ INDs filed and accepted; Source: https://ubrigene.com/
- EMA; Identifier: 20+ INDs filed and accepted; Source: https://ubrigene.com/
- FDA; Identifier: 20+ INDs filed and accepted; Source: https://ubrigene.com/

## Long description

uBriGene is a global leader in advanced therapy medicinal products (ATMPs), cell and gene therapy CDMO services, and analytical testing. Headquartered in Maryland with operations across North America and Asia, the company specializes in bridging ATMP concepts from early discovery through commercialization.

## Core Services

**Cell and Gene Therapy CDMO:** Robust platforms optimized for high quality and productivity, specializing in plasmids, mRNA-LNP, sgRNA, viral vectors (AAV, lentivirus, adenovirus), and cell therapy products including CAR-T, CAR-NK, iPSC, MSC, and TIL therapies.

**CRO Services:** Discovery and preclinical study support with production services for plasmids, mRNA-LNP, sgRNA, and viral vectors.

**Analytical Development & Testing:** State-of-the-art technologies and quality infrastructures ensuring product integrity and regulatory compliance, including cell therapy potency analytical development and GMP testing.

**Cell and Gene Therapy Products:** Ready-to-use R&D and GMP-grade products including plasmid products with activated Drug Master Files (DMF), AAV empty capsids in various serotypes, lentiviral vectors (GFP, GFP-Luciferase, CD19-CAR), iPSC generation products with mRNA-LNP reprogramming cocktails, and Ubrinuclease enzyme products.

## Infrastructure & Track Record

- 6 Centers of Excellence for manufacturing and testing
- >150 GMP batches successfully delivered
- 20+ INDs filed and accepted with FDA, EMA, and CDE
- Perfect audit record from over 100 clients
- State-of-the-art GMP facilities with integrated technology platforms

## Expertise

Extensive experience in manufacturing, QC testing, and regulatory filing across preclinical studies, IND enabling, and commercialization stages. The company emphasizes innovation, quality systems, client-centric collaboration, and local accessibility on a global basis.

_Profile last updated: 2026-06-10T01:45:45.348Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.