Achieve Efficient Viral Vector Production at any Phase with Proven Process Platforms

The Challenge: Building Scalable Viral Vector Programs

Cell and gene therapies offer unprecedented hope for previously untreatable diseases. At the heart of many of these advanced therapies, including both gene therapies and gene-modified cell therapies, are viral vectors, particularly Adeno-Associated Vectors (AAV) and Lentiviral Vectors (LVV), which serve as crucial gene-delivery vehicles.

The therapeutic potential is significant, but development to commercialization involves complex manufacturing challenges. These include the intricate development and scale-up of viral vector processes, a lack of standardized approaches, and the critical need for safe, robust, and cost-effective production to meet patient demands and accelerate clinical timelines. 

The AGC Biologics solution: BravoAAV™ and ProntoLVV™

AGC Biologics, proactively addressed these manufacturing hurdles by developing proprietary, ready-to-use manufacturing platforms for production needs at any phase: BravoAAV™ and ProntoLVV™. These integrated platforms are designed for the efficient production of AAV and LVV at various scales, accommodating both adhesion and suspension cell culture methods. Built on a foundation of shared process steps, common equipment, and standardized reagents, these platforms offer flexibility to adapt to diverse Genes of Interest (GOIs) and various AAV serotypes. Notably, our robust LVV services are well-suited to support the unique requirements of gene-modified cell therapy development and manufacturing. 

The CDMO’s approach recognizes the nuanced differences between AAV and LVV biology and their manufacturing implications. This deep understanding enables AGC Biologics to offer unparalleled flexibility, capacity, and capability as a CDMO. Key aspects of the AGC Biologics solution include:

• Plug & Play Vector Platforms: BravoAAV and ProntoLVV expedite the transition to GMP manufacturing with minimal development work. These platforms encompass GMP-released Master Cell Banks and Working Cell Banks, off-the-shelf packaging plasmids, and a comprehensive suite of analytical methods for vector release and characterization. This streamlined approach aims for GMP product readiness in as little as 9-12 months from plasmid.

• Scalable Equipment Integration: Availability of robust, multi-scale manufacturing equipment is a cornerstone of our success. Our facilities are equipped with bioreactors and purification systems suitable for a range of process scales, from small scale 1 L bioreactors, to 50 L to 2,000 L, ensuring seamless scale-up and tech transfer capabilities.

• Optimized Process Flow: The platforms have refined the entire manufacturing process, from cell thawing and expansion to vector harvest, clarification, purification, concentration, diafiltration, and final sterilizing filtration. This includes meticulous optimization of each step ensuring high recovery and effective impurity clearance. 

• Quality by Design: Our platforms are designed to achieve high-quality batches with low impurity levels. For instance, the use of affinity resins specific for AAV serotypes and careful optimization of anionic exchange chromatography for LVV lead to efficient impurity reduction and high impurity clearance.

The Benefits of our Viral Vector Platforms

High productivity, quality, and accelerated timelines

The implementation of BravoAAV and ProntoLVV has consistently delivered exceptional results, demonstrating AGC Biologics' ability to meet the critical demands of the cell and gene market:

• High Productivity: Our platforms enable the attainment of high-productivity batches across different scales.

• Robust Impurity Profiles: Through rigorous process optimization and advanced purification strategies, our platforms consistently yield viral vectors with high quality and significantly reduced impurity levels.

• Scalability and Flexibility: The platforms demonstrate excellent adaptability to various production scales, allowing clients to progress from early-stage development to commercial manufacturing seamlessly.

• Accelerated Development: The "plug and play" nature of our platforms, coupled with pre-defined processes and readily qualified and validated analytical methods, dramatically shortens development timelines.

The BravoAAV and ProntoLVV platforms ensure developers benefit from a flexible, high-capacity, and capable process that is scalable from the clinic to commercial phases. By doing this, developers can get safe, robust, and cost-effective manufacturing processes that support the urgent demands of the patient population and accelerate the promise of both gene therapies and gene-modified cell therapies.