The Chemistry, Manufacturing and Control (CMC) Division is engaged in the research needed to produce drug substances and products, as well as overall operations related to quality assurance. The three essentials of pharmaceuticals are efficacy, safety, and quality. The CMC Division is responsible for the quality of Taihoʼs investigational products. There are two aspects of quality; the tangible, such as drug substances and drug products; and the intangible, such as quality information and compliance with various regulations.
Thus, the Division has a responsibility to provide both pharmaceuticals and quality information in a timely manner while complying with global standards. It does this by working closely with numerous relevant external partners and internal departments at stages ranging from drug discovery to preclinical and clinical development, in-licensing and out-licensing, application for approval, and post-launch activities.
The Division is also involved in new formulation development to provide patients and medical staff with added value and improve the usability and therapeutic usefulness of drugs in terms of efficacy and safety.
The CMC Strategy Department is responsible for planning and strategy related to CMC operation and organization, and CMC research promotion overall, and it works in cooperation with relevant departments in the company.
The Formulation Research Laboratory develops drug product formulations, packaging configurations suited to various profiles of new chemical entities and clinical administration methods. It also works to develop different dosage forms for current products, novel dosage forms and DDS.* The manufacturing of investigational products is another of its important tasks.
The Analytical Science Laboratory develops test methods and specifications for drug products. It also establishes the transportation and storage conditions and expiry periods for drug products based on various stability studies. Further, it conducts quality control and quality assurance for investigational drugs.
The Chemical Technology Laboratory develops the synthesis process and the scaling up for new chemical entities, manufactures drug substances for investigational products, and establishes specifications and testing methods, transportation and storage conditions, and expiry periods for drug substances based on various stability studies. It also works on quality control and quality assurance for drug substances.
※DDS: Drug delivery systems
Technology to deliver the needed amount of drug to the site of action at the needed time.