Genevoyager has announced the opening of its contract development and manufacturing organisation (CDMO) facility to manufacture gene therapy products.
The new cGMP [current good manufacturing practice] compliant facility is equipped with the company’s One-Bac 4.0 System with Sf-RVF cell line and adheres to National Medical Products Administration, Food and Drug Administration and European Medicines Agency standards.
Spread over 68,000ft², the plant is designed to support the development, production and scaling of adeno-associated virus (AAV) gene therapy products.
Genevoyager will offer development and manufacturing services for AAV, oncolytic viruses, lentivirus and recombinant proteins.
The company’s One-Bac 4.0 system is an insect baculovirus platform that introduces a new approach to regulating AAV expression cassettes.
It intends to overcome existing issues in AAV-based gene therapy products by delivering stability and increased yields during scale-up production, ranging from 1E+15 to 5E+15 vg/L for volumes between 500L and 2,000L.
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The system also guarantees safety by reducing impurities and eliminating replication-competent AAV (rcAAV).
It offers increased infectivity and full capsid ratios of more than 70% in crude harvest.
The system could also make gene therapy more easily accessible by cutting down manufacturing expenses, thereby facilitating an affordable pricing model that can meet the medical needs of a wider patient population.
Through the CDMO facility opening, the company aims to advance healthcare through gene therapy solutions.
Genevoyager CEO Dr Xiaobing He stated: “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 company provides contract research organisation/CDMO services for gene therapy products and has a technology platform for large-scale AAV production and cGMP facilities.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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