連続生産研究会発足に向けて
研究会代表 竹内洋文（岐阜薬科大学教授）
医薬品生産に連続生産の大きな波が押し寄せて来ています。すでに、製剤製造に関して多くの経験と技術を有する我が国の製薬メーカーあるいは関連業界において、この波をどう受け止めるか、たいへん重要な時期の真っただ中にあると思います。
連続生産の実際を少し学んでみると、これまでの技術を生かすだけでは乗り越えられない生産システム上の大きな違いを感じます。ＰＡＴツールの導入には繋がるところはありますが、システムを管理し、品質を保証すると言う観点では別物と捉えた方が良いと思われます。当然、コストを極力抑えることは産業にとって常識ではありますが、そのためのシステム造りには、事前の準備と入念な実験が必要と強く感じるところです。
そのような中、私たちは、産・学の英知を結集して官とも協働できる仕組みづくりを早急にすべきであると考えるに至りました。欧米では、製薬産業と大学を基盤とするコンソーシアムが活動し、連続生産の発展を支えようとしています。日本においてもこのような形が必須であると言う点が、本研究会の発起人一同の強い思いです。
本年度末にはそのような活動の中心の一つであるラトガース大学との交流講演会も企画しています。是非、このような研究会を一緒になって立ち上げていただきたく本メッセージを発信させていただきます。
Message on Inauguration of Continuous Manufacturing Study Group
Hirofumi Takeuchi, Representative of Study Group
Professor of Gifu Pharmaceutical University
A great wave of continuous manufacturing is coming to the pharmaceutical production sites. Japanese pharmaceutical manufacturers and other operators in relevant industries that have accumulated vast experience and technologies for pharmaceutical production are now asked how they respond to the wave. It can be said that they are in the midst of a crucial period.
Just a little study of some reality of continuous manufacturing would make us realize that there are substantial gaps in the production systems that cannot be overcome only by leveraging conventional technologies in hand. Although both methods use PAT tools, continuous manufacturing should be taken as a completely different approach in terms of system control and quality assurance. As a matter of course, minimizing cost is a common objective in every industry; however, to establish a system that enables this to be achieved, prior preparation and elaborative experiments are needed, which is what we strongly feel now.
In these circumstances, we have concluded that we should urgently develop a new framework, in which all of us in the industry and academia sectors can combine our wisdom and knowledge and also work together with the public sector. In Europe and the United States, consortiums founded mainly by the pharmaceutical companies and universities are in operation to support the development of continuous manufacturing technologies. All the founders of the Study Group have the firm conviction that the same approach is absolutely necessary also in Japan.
We are planning to organize a conference at the end of this fiscal year to exchange information with Rutgers University. This is one of the core elements of the collaborative activities. I am sending this message in the hope that you would participate in the launch of the Continuous Manufacturing Study Group.