Viralgen

Overview

Viralgen is a contract development and manufacturing organization (CDMO) dedicated exclusively to adeno-associated virus (AAV) gene therapy production. Founded in 2017 as a subsidiary of AskBio Inc. (within the Bayer AG group), Viralgen operates the world's largest manufacturing capacity dedicated to AAV, serving clients from early construct optimization through commercial-stage production.

Manufacturing Capabilities

Viralgen specializes in the production of AAV gene therapy vectors using a proprietary suspension, triple transfection platform featuring the AskBio Pro10™ HEK293 cell line, known for delivering high yields. The company offers:

• Scale range: 100 mL to 2,000 L production capacity
• Serotype diversity: 30+ AAV serotypes produced
• cGMP compliance: Three cGMP suites with 2,000-liter capacities each, certified by AEMPS/EMA
• Production volume: 1,500+ AAV batches run; 100+ cGMP runs at 250/500 L scale
• Quality assurance: Integrated QC and release support with >85% of methods performed in-house

Service Portfolio

Services span the full development and manufacturing lifecycle:

• Construct optimization and platform fit assessment
• Manufacturing platform development
• Clinical production
• Commercial production
• Fill and finish across multiple formats
• Regulatory support for CMC filings at all development stages
• Fixed-cost and all-inclusive pricing models

Regulatory Track Record

Viralgen reports a 100% success rate for IND/IMPD dossiers and has been at the center of more global regulatory submissions using a single-platform process than other gene therapy manufacturers in the past five years.

Facility & Team

Located in San Sebastián, Spain, Viralgen operates a 343,255 square-foot GMP-accredited facility staffed by more than 400 professionals. The facility emphasizes segregation and control of material flows, personnel flows, and product flows to support high utilization and lower cost of goods.

Customer Base & Mission

Viralgen serves 50+ gene therapy customers and supports 7+ foundations through compassionate manufacturing programs. The company is committed to advancing therapies for rare genetic and pathway diseases, with a focus on helping patients access life-changing and life-saving treatments.