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Pioneering the Path to Standardized Viral Vector Manufacturing

Pioneering the Path to Standardized Viral Vector Manufacturing

Revolutionizing viral vector manufacturing with standardized platforms, offering scalable and adaptable solutions for diverse gene therapy needs.

The demand for viral vectors is becoming increasingly complex in the rapidly evolving gene therapy market. Each client brings unique requirements based on clinical stage, therapeutic indication, and vector administration.

Recently, we sat down with Dr. Martina Brunati about how contract development and manufacturing organizations (CDMOs) are stepping up to offer innovative solutions to meet these diverse needs.

AGC Biologics has distinguished itself by providing a standardized approach to manufacturing adeno-associated viruses (AAV) and lentiviruses (LVV). This approach, supported by our proprietary ProntoLVV™ and BravoAAV™ platforms, caters to various production scales in adherent and suspension cultures.

"As a CDMO, being adaptable and quick to respond is crucial," Dr. Brunati states, emphasizing the importance of flexibility and responsiveness in meeting client demands. The introduction of standardized platforms has streamlined these processes, enhancing both quality and efficiency. Launched last year, the ProntoLVV™ and BravoAAV™ platforms are designed to support GMP production and advanced therapeutic phases. These platforms leverage AGC Biologics' 30 years of expertise in cell and gene therapy, incorporating GMP-released cell banks, off-the-shelf packaging plasmids, transfer plasmid backbones, and comprehensive analytical methods for vector release and characterization.

The capabilities and advantages of AGC Biologics' platform, specifically the suspension process, include unlimited scalability - up to 1,000 L for LVV and 2,000 L for AAV - using chemically defined, animal-free media. This scalability makes suspension processes particularly attractive. For clients who prefer adherent cell processes, AGC Biologics' platforms can scale up to 750 L for both vector types. This flexibility ensures that the company can accommodate a wide range of manufacturing preferences and requirements.

 Dr. Brunati also highlighted the importance of scale-down models in process development and optimization. These models are essential for testing changes on a smaller, yet representative scale before implementing them in large-scale production. This approach mitigates risks and ensures the robustness of the manufacturing process as projects advance toward commercialization.

AGC Biologics' is committed to innovation and quality in viral vector manufacturing, working to accelerate the development and availability of advanced gene therapies.

To learn more, visit: https://www.agcbio.com/capabilities/viral-vector.