ISPE Japan Affiliate Sees Excellence on Its US Plant Tour
Among the 19 professionals from across Japan who participated in the tour were Head of Secretariat Akihiro Matsui and Adjunct Director Michael J. Lucey, who jointly planned the tour with the Japan Affiliate’s Organizing Committee led by Affiliate Vice-Chair Hiroshi Sakai and Director Hirokazu Kisaka. Industry representation on the tour was broad, with seven members from pharmaceutical manufacturing companies, nine from the engineering/construction sector, and three from equipment manufacturers.
The following are highlights from some individual plant tours.
Takeda (Formerly Shire)
The tour’s first stop was the Takeda Los Angeles manufacturing plant. Tour members saw the large-scale quality control (QC) laboratory as well as the Building 8 purification manufacturing facility. These facilities were selected as ISPE 2018 Facility of the Year Award (FOYA) category winners for Operational Excellence and Facility Integration & Overall, respectively, with Building 8 selected as the overall 2018 FOYA winner. The QC lab functions as a control lab for next-generation plasma-derived therapy, for which global demand is increasing. An optimized developmental environment has been realized by incorporating an effective flow and an improved work environment into the facility design. The manufacturing facility was designed using building information modeling (BIM). The underpinning philosophy of BIM is that maintainability and operability should be considered at all times. On such basis, an optimal facility was realized through real-time review work during the construction, with feedback to the designers.
CONTINUUS Pharmaceuticals
The tour’s third stop was the CONTINUUS Pharmaceuticals facility in Woburn, Massachusetts, just outside of Boston. CONTINUUS is a spin-out company from a multiyear collaboration between the Massachusetts Institute of Technology and Novartis in the area of continuous manufacturing (i.e., the Novartis MIT Center for Continuous Manufacturing). Their novel platform technology, integrated continuous manufacturing (ICM), allows for end-to-end integration of the entire manufacturing process, from raw materials to final drug product, in a fully automated and seamless production line. Team members leverage their accumulated technical experience and know-how to enable this innovative system. It was noted that integrated continuous manufacturing can lower costs, reduce stock-piling, shorten development periods, and improve product quality. Tour members believed that adopting advanced manufacturing technologies such as integrated continuous manufacturing will increase the range of products brought to the market, ultimately improving patient access to high-quality life-saving drugs.
