10.23.17
VBL Therapeutics has opened its new gene therapy manufacturing plant in Modiin, Israel, which will serve as the commercial facility for production of the company’s lead candidate, ofranergene obadenovec (VB-111), a gene-based biologic for solid tumor indications, pending approval.
The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel with 20,000 sq.-ft. of designated space capable of manufacturing large-scale capacity of 1,000 liters and is scalable to 2,000 liters.
“Having a manufacturing facility in place is an important step as we make preparations for potential regulatory approval and commercialization of VB-111,” said Dror Harats, M.D., chief executive officer of VBL Therapeutics. “Manufacturing has often been a limiting factor for BLA approvals, including for breakthrough products, and we believe the opening of this facility, together with the upcoming completion of our ongoing pivotal trial in recurrent glioblastoma (rGBM), should keep us on track for a timely submission of our BLA.”
Ben Shapiro, M.D., Chairman of VBL Therapeutics, added, "The inauguration of the new facility represents a major milestone for VBL. Investing in the appropriate infrastructure is critical as we complete the necessary pre-launch activities for VB-111 and evolve from a small biotech enterprise into an integrated biopharma company."
The Modiin facility is the first commercial-scale gene therapy manufacturing facility in Israel with 20,000 sq.-ft. of designated space capable of manufacturing large-scale capacity of 1,000 liters and is scalable to 2,000 liters.
“Having a manufacturing facility in place is an important step as we make preparations for potential regulatory approval and commercialization of VB-111,” said Dror Harats, M.D., chief executive officer of VBL Therapeutics. “Manufacturing has often been a limiting factor for BLA approvals, including for breakthrough products, and we believe the opening of this facility, together with the upcoming completion of our ongoing pivotal trial in recurrent glioblastoma (rGBM), should keep us on track for a timely submission of our BLA.”
Ben Shapiro, M.D., Chairman of VBL Therapeutics, added, "The inauguration of the new facility represents a major milestone for VBL. Investing in the appropriate infrastructure is critical as we complete the necessary pre-launch activities for VB-111 and evolve from a small biotech enterprise into an integrated biopharma company."