Providing Value to Society through Our Business Activities
Contribution to a Healthy and Long-Living SocietyProviding Advanced Medical Care to Patients Faster
Contributing to Shortening the Period and Improving the Success Rate of Pharmaceutical Development for Clients
Enhancing Efficiency of Pharmaceutical Development
We develop and provide various pre-clinical efficacy evaluation models including the industry’s largest PDX* collection and screening services to select effective drug candidates from many such candidates. These efforts are contributing to improving the efficiency of pharmaceutical development for pharmaceutical companies. We also provide pre-clinical services using organoids known for having an extremely high similarity with organs. Tumor organoids reflect the tumor characteristics specific to patients. Therefore, it is possible to even more accurately predict the response to drug candidates. It is expected this will improve clinical success rates.
- * Patient-derived xenografts (PDX): This is a model in which tumor tissue derived from a patient is transplanted into an immunodeficient mouse. It is effective in selecting drug candidates because it allows an evaluation in an environment similar to that of humans.
Developing Diagnostic Reagents
We provide in vitro diagnostics, research reagents and diagnostic reagent materials. This provides wide-ranging support – from research to diagnosis. We also undertake the contracted development of companion diagnostics which identify patients for whom therapeutic effects can be expected and patients at high risk of developing serious side effects before the administration of pharmaceuticals. This is supporting the development of personalized medicine.
Additionally, we market a number of diagnostic reagents only available from Medical & Biological Laboratories (MBL). We are developing new diagnostic reagents using innovative technologies regardless of whether there are many or few patients with unmet needs, contributing to people’s health and the development of medicine.
Developing Companion Diagnostics for Cancer Treatment Tailored to Individual Patient Needs
MBL has developed and obtained manufacturing and marketing approval for MEBGEN™ BRAF Kit ("the reagent"), a companion diagnostic for malignant melanoma, a type of skin cancer. Melanoma is a cancer that occurs frequently in Caucasians, but the number of patients is increasing in Japan due to aging. In drug therapy for cancer patients, the therapeutic drug used depends on the genetic mutation in the cancer tissue. The reagent can detect BRAF gene mutations, which are more frequent in malignant melanoma, in the DNA of cancer tissue. Testing with this reagent prior to drug therapy allows the selection of therapeutic agents for BRAF gene mutations and increases the likelihood of positive outcomes.
On the other hand, tests using this reagent target cancer tissue, which puts a burden on patients. Therefore, we are developing reagents that can detect genetic mutations from DNA in blood. If these can be commercialized, testing will be possible with a simple blood collection, reducing the burden on patients. Moreover, such testing is much easier to implement, increasing the possibility of early detection of various cancers, and monitor recurrence after treatment. Since the target genes in the blood are small in number, there are many challenges to overcome before development. By solving these one by one and developing reagents with higher sensitivity, shorter measurement time, and lower cost, we will contribute to the development of personalized medicine and a healthy and long-living society.
Genetic Reagent Development Unit
Research and Development Division
Medical & Biological Laboratories
Shortening the Period of the Pharmaceutical Manufacturing Process
We have advanced technologies relating to analysis, cell line development and manufacturing process development in the development and manufacturing of biopharmaceuticals. With that technology, we also support the process development and manufacturing of molecules with complex structures. Furthermore, we provide an integrated service called “Gene to GMP in 9 months.” It covers the processes from cell line development to manufacturing process development, analysis and manufacturing. This contributes to shortening the period to establish manufacturing processes in biopharmaceutical development.
Providing Bioprocess Materials
We provide process materials used in biopharmaceutical manufacturing such as particles for purification of antibody pharmaceuticals. Our AmsphereTM A3, a protein A carrier for antibody pharmaceutical purification with its industry-leading performance, is being used in the manufacturing of more than 95 investigational new drugs around the world. It started to be used in the commercial production of antibody pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) in March 2022.
