Astellas has a responsibility to maintain a stable supply of high-quality products for patients who require pharmaceuticals and medical doctors. Moreover, the Company recognizes its additional major responsibility to protect the environment and ensure the safety of its employees in the research, production and supply of pharmaceuticals.

Astellas has established management systems for the environment, safety and quality control, and is working on a steady supply of high-quality and effective pharmaceuticals.

The Company maintains three engineering process development facilities, as well as 12 pharmaceutical plants. We undertake our task of monozukuri on a global basis, which includes the conducting of research on production methods for new drugs, and research targeted at drug commercialization, as well as the production of investigational new drugs used in clinical trials.

Technology Development

Establishment of a method for producing bulk pharmaceuticals	We develop the best production process, and establish the technology for producing pharmaceuticals in bulk. "The optimal process" means the realization of stable production at a low cost, simultaneously allowing for a reduced environmental load and improvements in safety.

Formulation design

In addition to realizing a drug's stability, reliability in production, and yield improvements, we must design drug formulations after determining the appropriate dosages for patients, as well as the ease of administration and identification. Following the product's launch on the market, we must work together with the marketing department and other departments to ensure that our customers' needs are being met.

Technology transfer from labs to plants	This stage serves as a bridge between the research and development stage and the production stage. Drawing on the technological development information available thus far, improvements are made to the production facilities and to the production process at pharmaceuticals plants in Japan and overseas.

Product supply

Manufacturing of pharmaceutical intermediates	Pharmaceutical products start with raw materials, and involve several steps aimed at producing chemical compounds (bulk pharmaceuticals). The substances at this stage are called pharmaceutical intermediates. Intermediates, like pharmaceutical products, must allow for stable production and high quality, and various kinds of technology are utilized.

Production of bulk Pharmaceuticals

The primary components of pharmaceutical products are called bulk pharmaceuticals. They are the key components of pharmaceuticals, and as such must allow for steady production, a stable supply, high quality and high yields. Other considerations generally include a low environmental burden with regard to the energy and other resources employed in the production of bulk pharmaceuticals, and it is important to take safety precautions for the employees involved in their production.

Production of formulations	Bulk pharmaceuticals, as the primary components, are processed and made into tablets, capsules, and injection form. It is necessary to prevent foreign matter from entering the batch during the manufacturing process, and careful attention must be paid during this process. Shipments are made following a final inspection to confirm product quality.

Technology development to reduce the environmental load

In the production of pharmaceuticals, a variety of chemical substances are employed, and these are emitted into the atmosphere and bodies of water during the production process. As part of its environmental protection measures, Astellas undertakes technology development aimed at reducing the environmental load from early in the product development stage through the entire production process.

For example, in our research on drug compound technologies, substitutes are sought for harmful substances, or else the amount used is decreased. Degradability of drug candidate compounds at a wastewater processing facility is currently under investigation. Such research will help the management to decide their future investments in plant and equipment for environmental preservation, and to identify key issues as swiftly as possible.