Pharmaceuticals composed mainly of the antibodies, which play the main role in the immune system of living organisms. Recent genomic analyses have identified the antigen molecules that can be the drug discovery targets and thereby increased the attention toward the antibody drugs as effective cures with fewer side effects.
To obtain approval for manufacture and sale as a pharmaceutical product, we compile application materials based on scientifically considered data and respond to inquiries from the authorities.
Collagen with low antigenicity, obtained by eliminating telopeptide that is the main antigenic site of collagen.
It is applied as the materials of medical implants as well as of tissue-engineering scaffoldings.
This is a term created by combining "chemistry" and "metrics." It is a science applying mathematical and / or statistical techniques for extracting useful information from a large amount of data obtained from chemical experiments.
Drug form deployment
We conduct research for responding to a wide range of requirements from patients and medical personnel in pursuit of the further evolution of pharmaceutical products by improving their handling and ease of intake as well as drug compliance and adherence.
A pharmaceutical or agrichemical product that is processed into an easy-to-use form by blending additives, etc. to the active ingredients.
The form of a pharmaceutical product (injectable drug, tablet, patch, etc,) is designed in consideration of the actual patients taking it, their clinical states and the needs of the sites of medical care so that the compound can manifest its maximum potential.
The manufacturing method that can best ensure the safe, stable production of safe, high-quality drugs in actual production facilities is selected, while also responding to environmental considerations.
Refers to testing with which an environment similar to that inside the living body is created in a test tube or culture dish using human or animal tissues and cells and the reaction against the drug inside the test tube or culture dish is detected.
Refers to testing with which the test subject substance is administered directly in the living body of a test animal, such as a mouse, and the reaction against the drug inside the living body or cell is detected.
One of the standards therapies for hepatocellular carcinoma. With this local therapy method, the anticancer ingredient is mixed in an oil-based contrast agent (fatty acid ethyl ester of iodized poppyseed oil), which acts as the suspension fluid, and administers the mixture in the hepatic artery.
Manufacturing process design
Manufacturing methods leading to stable commercial production are studied while solving various problems that would occur following an increase in manufacturing scale.
Nucleic acid drugs
Functional molecules with various functions created using nucleic acids. Major functional nucleic acids include the "antisense RNA" and "siRNA" that inhibits gene expressions and the "aptamers" which are nucleic acid antibodies bonding strongly to specific protein targets.
Exhaustive collection/analysis of various kinds of molecular information such as comprehensive gene expression information (transcriptome), the entire set of intracellular proteins (proteome) or the entire set of metabolic substances (metabolome).
A packaging form that can ensure quality throughout the warranty period is selected by considering various factors affecting the quality of pharmaceutical products. Bulk packaging is also considered to meet any need at the site of medical care. Furthermore, the optimum container material is selected by also considering environmental impact.
Physical properties research
Before developing a compound that can be the "seed" of a pharmaceutical product, its basic information is investigated from the viewpoint of physicochemical and biopharmaceutical properties.
POC (Proof Of Concept)
Confirmation of the expected characteristics, such as effects and side effects, with the human being. It is at the point of POC that the judgment is made on whether the drug candidate is worth development.
The synthesis method, enabling efficient supply of the investigational drug with optimum quality, is designed by also considering commercial production in the future.
Supply/quality management of investigational new drugs
For use in clinical trial studies, a reliable investigational new drug is developed under sufficient management of manufacturing facilities and processes.
The manufacturing and test methods established by industrialization research are transferred to (inherited by) the factory (production site).