PHILADELPHIA, Dec. 20, 2023 /PRNewswire/ — Genevoyager (Wuhan) Co., Ltd. (Genevoyager), a leading provider of one-stop CRO/CDMO services for gene therapy products, proudly announces the official opening of its Contract Development and Manufacturing Organization (CDMO) facility. This significant milestone marks a major leap forward in the company’s commitment to advancing healthcare through innovative gene therapy solutions.
The newly inaugurated cGMP facility is equipped with its proprietary One-Bac 4.0 System with Sf-RVF® cell line and adheres to the NMPA, FDA and EMA standards. Spanning 68,000 square feet, the facility is purpose-built to facilitate the seamless development, manufacturing, and scaling of AAV gene therapy products. With the operation of the facility, Genevoyager will provide development and manufacturing services for AAV, lentivirus, oncolytic viruses, and recombinant proteins.
The proprietary insect baculovirus system, One-Bac 4.0, developed by Genevoyager, applies a new strategy for the regulation of AAV expression cassettes. It aims to address the challenges in AAV-based gene therapy products by offering the following key benefits:
- Achieving stability and yields ranging from 1E+15 to 5E+15 vg/L during scale-up manufacturing (500L-2,000L),
- Ensuring high safety with minimal impurities, and the absence of replication-competent AAV (rcAAV),
- Delivering high potency through increased infectivity and high full capsid ratios (＞70% in crude harvest), enhancing the therapeutic efficacy,
- Providing high accessibility with reduced manufacturing costs, enabling an affordable pricing model that addresses the medical needs of a broad patient population.
The CEO of Genevoyager, Dr. Xiaobing He, said “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.”
Genevoyager is a leading provider of one-stop CRO/CDMO services for gene therapy products. With a proprietary technology platform for large-scale AAV production and cGMP facilities, Genevoyager is dedicated to advancing healthcare by supporting our partners to develop safe, effective, affordable, and accessible AAV gene therapy products to address unmet medical needs.
For more information, please visit us at www.genevoyager.com/en
Dr. Hui Wang, Head of US Business Development
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