Andelyn Biosciences

Overview

Andelyn Biosciences operates as a contract development and manufacturing organization (CDMO) focused on gene therapy manufacturing. The company emphasizes a digital-first approach through its proprietary DIGITAL CDMO® Platform, designed to maximize data value, ensure compliance, and enable secure collaboration with clients.

Core Capabilities

Plasmid DNA Manufacturing

• Full-scale plasmid DNA manufacturing services for cell and gene therapy applications
• Capacity to manufacture batches from small trials to clinical-scale production
• High-quality, reliable products for partner success

Viral Vector Manufacturing

• Viral Vector Core with dedicated laboratory space for AAV vector manufacturing
• Research-grade AAV production supporting preclinical studies
• Services include pilot studies, proof-of-concept, dose confirmation, and IND-enabling toxicology studies

Technology & Infrastructure

DIGITAL CDMO® Platform

• Data integrity by design as a core compliance and security priority
• Secure chain of custody for client data and electronic assets
• Integration with industry-recognized solutions: Trackwise Digital (QMS/DMS), Compliance Wire (LMS), LabVantage (LIMS), Blue Mountain (Regulatory Asset Manager), Box GxP (validated repository), and Tetrascience (GxP platform)
• Advanced capabilities leveraging AI for optimization
• Emphasis on collaboration, data integration, and visibility across development lifecycles

Facilities

Two purpose-built facilities located in Columbus, Ohio, designed to support projects from concept through commercialization with capacity for expansion.