Engaging in regenerative medicine and gene therapy
We will establish new manufacturing facilities in our Takatsuki Plant to enable compatibility for regenerative medicine and gene therapy products. We will adopt new modalities as we strive to engage in the CDMO business.
Partnered with Cyfuse, which possesses bio-3D printer technology, to engage in the business of manufacturing products for regenerative medicine.
In October 2020, we concluded a comprehensive partnership agreement with Cyfuse for the manufacturing of cell products.
In September 2021, we completed construction of a cell processing facility. We will expand into the contract manufacturing business in regenerative medicine field.
In November 2020, we concluded an agreement with ONODERA GT Pharma, Inc. concerning the manufacturing of gene therapy drugs. In the field of gene therapy, which is expected to be an innovative treatment method for various diseases, we will receive technology transfer on AAV vector products from the Gene Therapy Research Institute and aim to engage in contract manufacturing of gene therapy products.
Manufacturing Facilities
・Compliant with Japanese GMP, PIC/S GMP, and the Cartagena Protocol
・Flexible manufacturing from small-scale development batches to production volumes of up to 200 L
・Aseptic filtration, formulation, and fill-finish capabilities using an aseptic isolator system
・Advanced PIC/S GMP-compliant cleanrooms with robust environmental monitoring and data integrity controls
・Containment facilities for genetically modified organisms (GMOs)
Strengthening the Gene Therapy Development Value Chain
Taiyo Pharma Tech, together with Synplogen Co., Ltd. and U-Medico Inc., has entered into a partnership to form a “Shared Manufacturing Organization,” and created a framework that enables seamless development support for viral vector product candidates, from the research and development stage through the late stages of clinical development.
