MBL supplies high-quality, accurate/reliable, and safe in vitro diagnostic reagents produced using its comprehensive production technologies and uncompromising quality control perfected over the company’s half-century history.
Stable supply of high-quality, accurate/reliable, and safe diagnostic reagents
MBL produces high-quality in vitro diagnostic reagents and research reagents, fully conscious of its social mission to contribute to public health and scientific progress.
The Technical Department collaborates closely with the R&D Department in the production of in vitro diagnostic reagents and its raw materials, and in further improvement of the manufacturing system, development of new manufacturing system, and enhancement of productivity. The production technologies thus developed underpin the company’s ability to consistently supply high-value products.
MBL has approximately 75 individual in vitro diagnostics in its product list and conducts more than 1,000 performance evaluation tests each year. These performance tests are undertaken by rigorously trained and certified professionals.
Uncompromising quality control is the core basis of the supply of high-quality, accurate/reliable, and safe products that can provide accurate diagnostic results to individual patients.
The company’s production plant is located at Ina City, Nagano Prefecture. It is equipped with manufacturing facilities and equipment that conform to the requirements of overseas regulatory authorities, including the U.S. FDA.
Basic flow of in vitro diagnostic reagent production system
The above production process is followed over a period of two to three months for each product item. The plant at Ina City produces all products for the Japanese domestic market and those destined for the United States, Europe, Korea, and China.
MBL produces some 100 product items per month according to closely monitored and adjusted production schedules in order to realize multi-product item production based on an annual production plan established in line with the corporate business plan.
Most of MBL’s products are made using biological materials derived from microorganisms and cultured cells. Product quality is controlled by regulating fluctuations in physical, chemical, and biological properties.
*In-house preparation of raw materials, including antigens and antibodies, and procurement of other raw materials for production
What MBL values at the production site
Medium- to long-term vision How MBL can contribute to the health of the general public and to medical progress
MBL implements the following plans concerning the production system and quality control, in accordance with its corporate philosophy and medium- to long-term management plan.
Planning and execution of innovative manufacturing processes
Every MBL product is essential for the diagnosis of clinical condition and determination of treatment regimen in each patient. It is therefore the basis of MBL’s mission to consistently provide high-quality products.
MBL products are made using biological materials derived from microorganisms and cultured cells. Control of product quality requires the know-how to regulate fluctuations in physical, chemical, and biological properties. MBL is promoting digitalization and automation of this know-how and progressively introducing new operating systems and equipment required for stable production in order to consistently provide high-quality products.
Strengthening of production system at Ina plant
- Research and development of raw materials for diagnostics
- Research and development of reagents
- Clinical performance study and pharmaceutical licensing application
- Production system
- Quality management
- Product examples