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Japan-based Chugai Pharmaceutical has announced its decision to construct a new bio active pharmaceutical ingredients (APIs) manufacturing building and injection building in the Utsunomiya Plant of Chugai Pharma Manufacturing, a member of the Chugai Group.
The new bio-API manufacturing building (UT3) will target the clinical development stage to initial commercial production by establishing a new facility for middle to later-stage manufacturing of investigational drugs, including Phase 1 and 2 projects.
Together with the bio-API manufacturing building for early-stage clinical development (UK4), currently under construction at the Ukima Site, and existing manufacturing buildings, investment in UT3 will further strengthen the in-house supply foundation from clinical development to initial production, thereby contributing to the rapid launch of in-house products.
UT3 will also implement continuous production functions by introducing perfusion culture, in addition to the conventional batch-type production system, promoting initiatives to realize the concept of a next-generation biopharmaceutical factory.
The new injection building (UTA) will be responsible for manufacturing sterile injectables for initial commercial use. New formulation technology will be introduced to support the formulation of complex structured antibodies using Chugai’s proprietary antibody engineering technologies. Furthermore, using robotics will enable high-mix, low-volume manufacturing in response to a wide variety of dosage forms that will lead to patient convenience.
