PHILADELPHIA, PA — Genevoyager (Wuhan) Co., Ltd. has announced the opening of its new Contract Development and Manufacturing Organization (CDMO) facility. This development underscores the company’s commitment to advancing healthcare through innovative gene therapy solutions.
The newly established facility, built to meet NMPA, FDA, and EMA standards, spans an impressive 68,000 square feet. It is specifically designed to facilitate the seamless development, manufacturing, and scaling of AAV gene therapy products. Leveraging the facility’s capabilities, Genevoyager plans to provide comprehensive development and manufacturing services for AAV, lentivirus, oncolytic viruses, and recombinant proteins.
At the heart of the facility is Genevoyager’s propriety One-Bac 4.0 System with Sf-RVF® cell line. This innovative insect baculovirus system represents a fresh approach to regulating AAV expression cassettes, aiming to tackle the challenges inherent in AAV-based gene therapy products.
The One-Bac 4.0 System offers several key advantages. It ensures stability and high yields during scale-up manufacturing, ranging from 1E+15 to 5E+15 vg/L for batches between 500L-2,000L. The system guarantees safety by minimizing impurities and eliminating replication-competent AAV (rcAAV). Furthermore, it delivers high potency through increased infectivity and high full capsid ratios (＞70% in crude harvest), thereby enhancing therapeutic efficacy.
Perhaps one of the most significant benefits of the One-Bac 4.0 System is its potential to make gene therapy more accessible. By reducing manufacturing costs, Genevoyager can offer an affordable pricing model that meets the medical needs of a broad patient population.
Dr. Xiaobing He, CEO of Genevoyager, expressed his excitement about the new facility, saying, “We are thrilled to unveil our state-of-the-art CDMO facility. With our revolutionary insect baculovirus system addressing the complexities of AAV manufacturing, particularly for systemically administered gene therapy products, we are forging a pathway to provide high-quality and affordable gene therapies to patients worldwide.”
The opening of Genevoyager’s CDMO facility marks a significant leap forward in the gene therapy industry. By addressing some of the most pressing challenges in AAV-based gene therapy production, the company is positioning itself at the forefront of the industry’s evolution. As the industry continues to grow, Genevoyager’s innovative approach may well set a new standard for high-quality, affordable gene therapies.
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