Viral Vector Manufacturing
From development through final fill-finish, we provide end-to-end development and manufacturing support for gene therapies.
Manufacturing Area
Operations are conducted in compliance with Japan’s GMP and PIC/S GMP standards, meeting BSL-2 and Cartagena Protocol requirements.
We provide end-to-end services from cell banking to final packaging and accommodate projects from small-scale production to commercial manufacturing, including preclinical and clinical trial drug production.
Upstream Manufacturing
Supports production using suspension cells at scales ranging from 10 L to 200 L; production using adherent cells is also supported. The entire process utilizes single-use technology.
Downstream Manufacturing
Supports purification via affinity chromatography, anion-exchange chromatography, and ultracentrifugation; the entire process utilizes single-use technology.
Aseptic Fill-Finish Area
Filling operations are conducted within a Grade A aseptic isolator, accommodating vial sizes up to 25 mL. We accept contract manufacturing requests for the filling process, handling everything from small-batch runs.
Laboratory Area
In the non-GMP area, we can perform the entire viral vector manufacturing process, ranging from cell culture to purification and concentration. Operations can be scaled from flask-level up to medium-scale production.
The area is fully equipped with testing instruments, such as cell counters, enabling the preliminary verification of manufacturing methods under scale-down conditions prior to actual GMP production.