OBiO Technology, a gene and cell therapy CDMO in China, and Univercells Technologies, entered into a strategic agreement to deploy novel technologies in Shanghai. The NevoLine Upstream biomanufacturing platform with scale-X bioreactors will now be offered in OBiO’s recently expanded (+828,00 ft2) GMP Shanghai facility to accelerate gene therapy manufacturing.

The strategic agreement combines the capacity and capabilities of OBiO process development scientists with enabling platforms and support from Univercells Technologies, according to officials at both companies, who add that the combined know-how and capabilities will put OBiO in the position to offer GMP manufacturing services from R&D to commercial stages to gene therapy developers.

“Bringing gene therapies to market safely requires reliable, scalable manufacturing technologies. We were intrigued by the potential and became early adopters of the scale-X technology in 2020. Our recently published poster details the successful scale-up of an oncolytic Herpes Simplex Virus Type-1 (HSV-1) vector from scale-X hydro (2.4 m²) to scale-X carbo bioreactor (30 m²), with  significant reductions in manpower, materials and space requirements,” said Jia Guodong, CEO, OBiO.

“We will pursue this comprehensive collaboration with Univercells Technologies in multi products, conducting process development in the advanced fixed-bed bioreactor not only for HSV, but also for Lentiviral vector, Adeno-associated virus, and other cell and gene therapy modalities.”

“As we enter this agreement, the teams are already planning to scale up the oncolytic HSV-1 process in the 600m² scale-X nitro integrated in the continuous NevoLine Upstream platform,” added Florence Vicaire, CCO, Univercells Technologies. We look forward to further increasing their OBiO’s capabilities to meet the growing demand for gene therapies at a reduced cost, in China and globally.”

cGMP manufacturing partnership

Separately, The New Hope Research Foundation, a nonprofit organization dedicated to finding a genetic cure for GM2 gangliosidosis (including Tay-Sachs) and other lysosomal storage diseases, and Forge Biologics signed a development and cGMP manufacturing partnership agreement to advance the Foundation’s novel gene therapy, NHR01, into Phase I/II clinical trials for patients with GM2 gangliosidosis.

According to Timothy J. Miller, PhD, CEO, president, and co-founder of Forge Biologics, “Forge will provide adeno-associated virus (AAV) process development, analytical services, and cGMP manufacturing. The Foundation will leverage Forge’s platform processes, including its proprietary HEK293 suspension Ignition Cells™, to accelerate the initial production. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 ft2 gene therapy facility in Columbus, OH.”

“We look forward to embarking on our manufacturing collaboration with their experienced team and tried and true platform process to help accelerate our therapy into clinical trials and deliver new hope for patients with GM2 gangliosidosis,” said Jack Keimel, co-founder, and president of New Hope Research Foundation.

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