It is very import to develop vaccines with new strategies against emerging and reemerging infectious diseases such as new influenza epidemic. New methods of vaccine inoculation to individuals leading mucosal immunity, development of novel adjuvants and microbial vectors to able to induce more immunity are needed for future vaccines development. Furthermore, it is urgent to have a guideline for new vaccine development. Therefore, intimate collaboration between researchers in academic fields and industrial groups to realize new development of vaccines is expected

BIKEN has developed and produced various kinds of Japan's first vaccines, including influenza vaccine, measles vaccine, and rubella vaccine. In particular, its Oka strain of varicella vaccine is the sole vaccine used in the world. While BIKEN was established for the purpose of protecting Japanese people from infectious diseases, hereafter, we attempt to develop and produce vaccines for people in the world. On this occasion, I will comment on new vaccines under development in BIKEN and will discuss about the prospect of these vaccines.

Recent innovative technologies, namely searching antigen, adjuvant, advanced manufacturing methods and various devices for delivery can be applicable to overall design for novel vaccines. Taking advantage of these technologies, we hope to expand our scope of collaboration with domestic and overseas institutes / companies (Open-innovation) for creating the next generation vaccines that are matching with various customer needs.

In the new drug approval review, more and more importance is put on the process of establishing manufacturing process and process control, and on the assurance of robustness in manufacturing. Explanation will be extended on the possibility and control of unavoidable contamination of impurity in manufacturing, problems found during review of new drugs and trend in the future.

In order to keep high quality of the pharmaceuticals, the activities of pharmaceutical companies should be to secure safety with maximum displaying of the effectiveness of the pharmaceuticals. Especially, the impurity controls in manufacturing pharmaceuticals will be an extremely important strategy for CMC (Chemistry, manufacturing and Control) of the pharmaceutical company from the viewpoint of the safety securing. In this lecture, the control of impurities in drug substance (impurities originated from raw materials, by-products in synthesis and degradants under storage condition) and strategic analytical methods for impurity control will be introduced.

Profound insight into the manufacturing process becomes much more vital for the control of impurities in API and stable supply of high quality pharmaceuticals. In order to provide patients with the high quality pharmaceuticals which meet medical needs as fast as possible, productivity of CMC research becomes increasingly indispensable. The current API process development environment and our approach will be introduced.

In Japan and most other developed countries around the world, the pharmaceutical industry is facing new and formidable challenges. With rising healthcare costs, governments are putting pressure on the prices of medicines. In addition the tight financial situation and lack of new innovation is increasingly forcing pharmaceutical innovators to make difficult choices on how to spend their resources; discovery, development & marketing and manufacturing. Globalisation not only offers challenges but also solutions and opportunities. New market opportunities as well as access to new service providers which can help address the cost pressures as well as lack of innovation in the industry today. Accepting what pharmaceutical customers want and need, Affordable & Innovative Medicines, focuses our choices in the right direction.

The companies in custom manufacturing are facing the lower number of new drug approvals, and the competition from India and China. These factors require contract manufactures to maintain competitive edge by speed, cost and quality control, as well as differentiating technologies, especially for API production.
In this presentation, we will explore several case studies from our recent projects, and show how we developed efficient processes and applied the latest technologies such as microreactors into manufacturing pharmaceutical intermediates.

TFC, TFT, and TSO are Tosoh Corporation subsidiaries prominent in organic intermediates, particularly in custom synthesis. TFC excels in organometallic coupling, TFT in fluorination, and TSO in bromination and chlorination. Tosoh management policy is to enhance each subsidiary's longtime technological strengths and to foster their sharing of their respective organic synthesis technologies. My speech introduces the activities of these companies and the advantages of encouraging the synergies among them.