Sugiyama Laboratory

SoliDecision

Our group has released the prototype version of "SoliDecision," which is an economic assessment tool for solid drug product manufacturing.
Solid drug products, such as tablets and capsules, can be produced by various types of processes. Recently, continuous manufacturing, which interconnects production units from raw materials to final products, has been developed as an alternative to the conventional batch manufacturing. Because of the rise of process alternatives, the process design of solid drug product manufacturing has become complicated; a holistic method or tool is now required.

We have developed a tool for generating process alternatives in solid drug product manufacturing comprehensively and performing an economic assessment [1, 2]. The prototype version is released at the same time with the publication in BMC Chemical Engineering [1]. It is now possible to consider uncertainty from the clinical development to commercial production by setting probability density functions of input parameters, which might change the assessment results. In the future, we will implement “SoliDecision” further and develop a more theoretical process design.

If you are interested in the usage of the prototype version, please read Terms of Use and send an e-mail to solidecision(at)pse.t.u-tokyo.ac.jp.

[1] Kensaku Matsunami, Fabian Sternal, Keita Yaginuma, Shuichi Tanabe, Hiroshi Nakagawa, Hirokazu Sugiyama, "Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing" BMC Chemical Engineering, 2, 6 (2020)
[2] Kensaku Matsunami, Keita Miyano, Hiroaki Arai, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama, "Decision support method for the choice between batch and continuous technologies in solid drug product manufacturing" Industrial & Engineering Chemistry Research, 57(30), 9798–9809 (2018)

Latest update: 11 March 2020

This is a prototype tool that enables comprehensive and quantitative evaluation of single-use and multi-use technologies in sterile filling processes of biopharmaceutical manufacturing [1]. Our group has developed a selection support methodology for the choice of the equipment technology by economic and environmental impacts, and product quality and supply robustness aspects [2–4]. The online tool "TECHoice" can demonstrate the developed tool on a web browser, and allows free access by various users, such as pharmaceutical manufacturing companies.

You can use the software from here.

[1] Haruku Shirahata, Sara Badr, Yuki Shinno, Shuta Hagimori, Hirokazu Sugiyama, “Online decision-support tool “TECHoice” for the equipment technology choice in sterile filling processes of biopharmaceuticals” Processes, 7(7), 448 (2019)
[2] Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama, "Decision-support method for the choice between single-use and multi-use technologies in sterile drug product manufacturing" Journal of Pharmaceutical Innovation, 12(1), 1–13 (2017)
[3] Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama, "Multiobjective decision-support tools for the choice between single-use and multi-use technologies in sterile filling of biopharmaceuticals" Computers & Chemical Engineering, 122, 114–128 (2019)
[4] Haruku Shirahata, Sara Badr, Shant Dakessian, Hirokazu Sugiyama, "Alternative generation and multiobjective evaluation using a design framework: case study on sterile filling processes of biopharmaceuticals" Computers & Chemical Engineering, 123, 286–299 (2019)

Latest update: 16 July 2019