CMC Development Dept. / Technology Development Dept.
Organization Overview
The CMC Development Department / Technology Development Department primarily focuses on the CDMO business, handling process development and contract manufacturing of active pharmaceutical ingredients (APIs) and intermediates on a global scale. Additionally, we also conduct CMC development* for pharmaceutical candidate compounds created through drug discovery research. With development bases in Ube and Yoshitomi (formerly API Corporation), we contribute to the further advancement of the pharmaceutical industry by providing high-quality services that meet various needs, such as process development and regulatory documentation preparation.
Furthermore, leveraging our expertise in organic synthesis and process chemistry technologies for small-molecule pharmaceuticals,
we are also engaged in the development and optimization of manufacturing processes for nucleic acid pharmaceuticals, which are medium-molecule drugs, as well as highly flexible flow synthesis technologies that do not require large-scale equipment.
* UBE primarily focuses on process and analytical method development for APIs.
CDMO: Contract Development and Manufacturing Organization
CMC: Chemistry, Manufacturing, and Control
Main Operations
In alignment with the business strategy of the Pharmaceutical Business Unit, we collaborate with various departments within the unit, as well as the Ube Pharmaceutical Plant and Yoshitomi Plant. Our primary responsibilities include CMC development and manufacturing facility design, following pharmaceutical development regulations. We handle tasks such as manufacturing process evaluation, analytical method evaluation, regulatory submissions, safety assessments, feasibility studies (FS), scale-up validation, basic design of commercial manufacturing facilities, support for commercial production launch (validation manufacturing), and technology transfer to external partners.
Main Products
Please refer to the Contract Manufacturing of Pharmaceutical APIs and Intermediates page.
Structure / Development Bases
UBE has development bases,
located across Japan.
