Background to Development

In the later 1970s, Central Glass began basic research into the production of organic fluorine compounds. The compounds that have been developed since that time are the raw material for the fluorine-based general anesthetic sevoflurane. The development of these compounds marked the beginning of Central Glass pharmaceutical production. At the time, Maruishi Pharmaceutical had slated sevoflurane for development, and this development work was begun with Central Glass because of our expertise in fluorine chemistry.
Central Glass supplied the anesthetics API, Active Pharmaceutical Ingredient, for clinical trials and collected data to establish commercial production technologies for the anesthetic API. At the time, we built a plant that followed Good Manufacturing Practice (GMP) for API production in which we had absolutely no experience. Having obtained approval for sevoflurane in 1990, we started production at the Ube Plant. In 1995, Abbott Laboratories (currently AbbVie) obtained a license from Maruishi Pharmaceutical to begin overseas sales. Sales in Japan and overseas by the two companies have now made sevoflurane the world's leading inhalational anesthetic. It is used to assist in important surgical procedures in operating rooms around the world.

Challenges from Development to Production

At the time, although Central Glass had plenty of know-how in chemical synthesis, our knowledge of API production technology was almost nothing, and we didn't have any experienced people in house.
When it came to ramping up production of sevoflurane, we brought in outside advisors to school us in the culture of pharmaceutical quality management system and quickly set up the pharmaceutical quality control and quality assurance systems. In manufacturing the API products, we had to ensure we were fully compliant with GMP. Those rules are continuously revised, so we always had to follow the updated regulations, for which we should change our old ways of thinking that came out of traditional chemicals manufacturing and improve our internal systems.

Keys to Success

Know how to manage fluorine safety

A lot of fluorine compounds are useful for the pharmaceuticals. We at Central Glass are used to handling fluorine containing compounds. Our major strength in this R&D effort has been the fact that we have plenty of know-how in fluorine safety controls. Another strength would be the integration of product/technology portfolio in Fluorine chemistry from upstream to downstream products, which allow us the competitiveness in effective process and cost management Another key to our success lies in the features of the product: Sevoflurane is a high-quality, odorless anesthetic with rapid onset and no unpleasant feelings upon returning to consciousness.
The Central Glass sales department has many experienced scientists with registered pharmacists, PhDs, Master degrees and others with advanced degrees who come from R&D Center and/or plant. It would be very important to discuss interactively between the R&D people in the global pharmaceutical companies and scientists in our sales department. Through this interactive discussion, we would like to find the customers’ problems and needs, then come up with our solution from our expertise. Our goal is to support the customers’ projects through our R&D and production.