From West to East & Back: ISPE Japan Affiliate Sees Excellence

Akihiro Matsui
Michael J. Lucey
ISPE Japan Affiliate

Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.

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.

ISPE Japan Affiliate members
ISPE Japan Affiliate members visiting Eli Lilly’s continuous manufacturing facility in Indianapolis.

Eli Lilly

The tour’s final stop was Eli Lilly’s continuous manufacturing facility in Indianapolis. Members observed the operation of the continuous direct compression process and the low-molecular-weight compound production line. The direct compression process is the simplest form of process for tablet manufacturing, and it was noted that such a process makes continuous manufacturing relatively straightforward. Eli Lilly adopts simulation techniques and experimental approaches in evaluating fluctuating factors, and their quality management strategy has been established using process analytical technology (PAT) tools and modeling techniques. Tour members requested information on the type of evaluation techniques to be applied to quality management. Presently in Japan, this issue is also an important matter when pharmaceutical companies consider an approach to quality management. The visit provided a good opportunity for an enhanced understanding of Eli Lilly’s approach to quality management.


The Japan Affiliate is deeply grateful to the host plants for their valuable time shared throughout the US tour. It was a remarkable experience for all the traveling Japanese professionals.

As a change of pace, the group enjoyed a final, posttour afternoon of relaxation in Indianapolis, visiting the Indianapolis Motor Speedway and its Hall of Fame Museum. A member of the tour even “kissed the brick” of the Indy 500 finishing line.

The entire week was a period of bonding and establishing special friendships in our industry. To further expand the member network in Japan, the Japan Affiliate holds a reunion every year for all who have participated in the US pharmaceutical plant tour over the many years of its history. Additionally, the Japan Affiliate displayed the tour highlights in poster form at the winter meeting in December in Osaka.

ISPE Japan Affiliate US Plant Tour Itinerary

Sunday 20 October:

Departed Tokyo for Los Angeles

Monday 21 October:

Takeda (formerly Shire) (a.m.)
Gilead Sciences (p.m.)

Wednesday 23 October:

Continuus Pharmaceuticals, Boston

Friday 25 October:

Eli Lilly, Indianapolis

Sunday 27–30 October:

ISPE Annual Meeting & Expo