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Research and Development

Structure on R&D

Establish a Consistent System from Planning of Drug Discovery to Pharmacovigilance

In order to closely coordinate the process of drug development from upstream to downstream, Seikagaku establishes a consistent system throughout all related departments, mainly under the Research and Development Division. Using this integrated system, Seikagaku promotes wide-ranging activities related to drug discovery, from the search of candidate substances, the evaluation of efficacy, safety, and pharmacokinetics at the Central Research Laboratories, the production of investigational drugs, design of manufacturing processes and investigation of commercial production at the CMC Laboratories, and clinical development to post-marketing surveillance.

Central Research Laboratories

The Central Research Laboratories, the principal facilities for drug discovery, utilize advanced equipment. They operate in a way that encourages and promotes creativity among researchers and emphasizes a self-help culture in an enriched environment.

Recently, the lack of infrastructure has been suggested as one factor for the declining success rate of drug discovery throughout the pharmaceutical industry. The Central Research Laboratories accumulate scientific technologies and knowledge/experience differentiated from other companies. Furthermore, the Central Research Laboratories are actively developing collaboration/alliances with outside academic organizations and companies across the world in order to investigate ideas and promote basic research for development of new technologies. Through these efforts, we pursue the creation of new products, that other companies cannot imitate, based on specialized technologies and original ideas

<Overview of Research Units>

  • Glycoresearch: Exploration of GAGs (glycosaminoglycans) and related compounds as candidate substances
  • Chemistry: Synthesis of new candidate substances
  • Pharmacology: Evaluation of efficacy and study of action mechanism
  • Medicinal Safety & Pharmocokinetics: In vivo evaluation of pharmacokinetics and features causing side effects of candidate substances
  • Exploratory Formulation Research: Exploratory formulation research baced on basic physicochemical properties


CMC Laboratories

Seikagaku is building up an efficient system based on organic collaboration between R&D and the manufacturing organizations for supplying high-quality pharmaceuticals and medical devices in compliance with regulations in Japan, North America, and Europe. As part of this initiative, in April 2013 we established the CMC Laboratories to concentrate, within a single organization, CMC-related operations previously carried out by the Central Research Laboratories and manufacturing organizations and to further strengthen those functions. In this way, we seek to speed up new drug development in a consistent system extending from research to production.

<Overview of Labs' Units>

  • Pharmaceutical Technology: Design of a bulk product (an active pharmaceutical ingredient) for candidate substance, formulation, packaging, manufacturing processes and investigation of commercial production
  • Quality Development: Research of physical and chemical properties, development of testing methods for quality evaluation, and quality assurance of investigational drugs

*CMC is an abbreviation for Chemistry, Manufacturing and Controls.
CMC constitutes the part of pharmaceutical development that addresses and defines the nature of the drug substance and drug product, the processes in which both are made, and the manner by which the manufacturing process is shown to be in control.

R&D Structure Chart

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