Potency Assays to Support Regulatory-Ready Gene Therapy Products

Pharmaron’s expert team offers tailored potency assay development and validation for gene therapy viral vector programs, supporting regulatory submissions and lifecycle testing requirements. With GMP-accredited laboratories, Biosafety Level 1 and 2 capabilities, and in-house analytical cell bank generation, Pharmaron ensures that potency testing is precise, compliant, and aligned with product-specific mechanisms of action. Established in 2015, our potency platform supports a wide range of viral and biologic products through single or matrix-based assays—crucial for characterizing complex therapeutic effects in gene therapy development.

Expert Potency Testing Solutions

Core Capabilities:

• GMP-compliant potency assay development and validation
• Infectious titre assays optimized for multi-serotype AAV vectors
• Quantitative assays for gene editing efficiency (DNA/RNA/protein)
• Analytical cell bank production (RCB, MCB, WCB)

Multi-Endpoint Assay Formats:

• qPCR/ddPCR
• Flow cytometry
• ELISA / Western blot
• Imaging (live cell, fixed cell)
• Biolayer Interferometry
• Surface Plasmon Resonance (SPR)

Matrix-Based Assay Design:

For gene therapies with complex mechanisms, Pharmaron offers matrix assay approaches, combining orthogonal biological assays to fully characterize product potency throughout its lifecycle.

With validated potency assays, accelerate regulatory readiness for your gene therapy viral vector. Download the flyer to explore our full capabilities.