Accelerating Time-to-Clinic Through Innovative AAV GMP Manufacturing

Pharmaron delivers cutting-edge AAV GMP manufacturing solutions by integrating high-throughput analytics, platform-based development, and GMP-grade production—all designed to reduce timelines and streamline regulatory readiness. The capability to transition from development to clinical GMP manufacturing in as little as six months is also required. Pharmaron offers a unique end-to-end solution for gene therapy developers and biotech innovators.

What Sets Pharmaron Apart in GMP Manufacturing?

Our GMP manufacturing platform for adeno-associated virus (AAV) vectors is underpinned by:

• High-throughput robotic analytics (e.g., Biomek i7)
• DoE & mechanistic modeling platforms to optimize process variables
• GMP-grade starting materials like HEK293 cells and plasmids
• Consistent processes from small-scale (Ambr?15) to 50L production

We employ a tiered testing approach, enabling the rapid prioritization of optimal process candidates with reduced costs and increased assay complexity. Pharmaron is ideal for teams preparing for toxicology studies, IND submissions, or full clinical production.

Seamless Scale-Up and Quality Assurance

• Mirrored equipment/software between development and GMP sites
• Single-use technology across production to minimize contamination risks
• Continuity in data and personnel across R&D, tech transfer, and GMP
• Flexible batch scales (10L/50L) to meet early- and late-phase needs

Pharmaron’s multi-serotype platform allows rapid product fit assessment and tailored optimization. Analytical and process consistency are ensured through phase-appropriate validated GMP release assays and scalable chromatography techniques.

Download our flyer to learn how Pharmaron’s streamlined AAV manufacturing platform can accelerate your gene therapy from bench to bedside.