Japan: Chugai Pharma Manufacturing Co., Ltd., a subsidiary of the Chugai Group, announced its intention to develop a new bioactive pharmaceutical ingredients (APIs) manufacturing facility and injection building at its Utsunomiya Plant in Utsunomiya City, Tochigi Prefecture.

The new bio-API manufacturing building (UT3) will provide a new facility for intermediate to later-stage manufacturing of investigational pharmaceuticals, including phase 1 and 2 projects, with a focus on the clinical development stage to initial commercial production. Investment in UT3 will further strengthen the internal supply foundation from clinical development to initial production, which will aid in the quick launch of internal products. The Ukima Site is currently constructing UK4, a facility for early-stage clinical development bio-API manufacturing.

In addition to the traditional batch-type production system, UT3 will also implement continuous production functions by adding perfusion culture, supporting endeavours to realise the concept of a next-generation biopharmaceutical factory. The production of sterile injectables for initial commercial use will be handled by the new injection building (UTA). Utilising Chugai's unique antibody engineering technologies, new formulation technology will be introduced to facilitate the formulation of complicated structured antibodies. Robotics will also make it possible for high-mix, low-volume manufacturing in response to a wide range of dosage forms, which will benefit patients. At the same time, by utilising cutting-edge automatic driving technology and other digital technologies, we want to realise smart factories that significantly increase productivity.

The intricacy of producing such antibodies is rising as more companies use Chugai's own antibody engineering methods, which the company excels at. According to Osamu Okuda, obtaining the necessary technology and capacity to manage complex projects and enable in-house manufacturing from clinical development to initial commercial production can accelerate and customize in-house project development, resulting in a significant competitive advantage.

Employ digital technologies and robotics to drastically boost productivity and realise world-class pharmaceutical and manufacturing activities suited for a leading innovator in the healthcare business, in addition to pursuing sustainability, including environmental concern. We are dedicated to making sure that fresh drug discovery concepts from our research function become medications and benefit patients all around the world.

The Chugai Group's Mid-Term Environmental Goals 2030 will be achieved in part by the new production facilities, UT3 and UTA, which will encourage environmental burden reduction measures such chlorofluorocarbon-free and energy-saving design. Additionally, both structures will adopt the digital infrastructure needed to support the production function's new activities, which were developed and use in the Ukima Plant (project name: SPIRITS). Initiatives to realise robotically assisted, cost-competitive smart manufacturing will also pick up speed.