East to East: Japan Affiliate on the Road in the USA
Michael J. Lucey
First and foremost, the authors wish to express their sincere gratitude to the several persons in the US, former or present seniors in the ISPE global organization, and of course the host plants themselves, without whom the 2016 plant tour could not have been materialized. We are deeply grateful for the consideration extended to the Japan Affiliate.
Twenty-one professionals from the ISPE Japan Affiliate participated in its 13–16 September 2016 plant tour in the eastern United States, including Executive Director Akihiro Matsuki and Adjunct Director Michael J. Lucey, who had led the Organizing Committee made up of Affiliate board members. As in previous years, the mission was well balanced, with seven members from pharmaceutical companies, 10 from engineering/construction companies and four from equipment manufacturers.
Tour members visited MedImmune’s large-scale cell culture plant in Frederick, Maryland. The facility was impressive for flexibility of reactor layout and effective use of the multistory building. In addition, utmost consideration has been given to the prevention of operational error, including the adoption of training programs and highly reliable software for the manufacture of different kinds of products. For enhanced productivity, a three-shift basis is applied.
Biogen flexible volume manufacturing facility, Research Triangle Park, North Carolina
The Research Triangle Park, North Carolina, flexible volume manufacturing facility visited on this tour was established in 1995 and is a large-scale bio-production facility staffed with 1,100 employees and equipped with culture tanks having a total capacity of 90,000 liters. The facility is a hybrid combination of existing fixed facilities and single-use facilities. Biogen’s investment planning for equipment and facilities suggests a company having the momentum to grow in the future.
Merck vaccine production facility, Durham, North Carolina
Merck’s vaccine production facility in Durham, North Carolina, was the next visit. Merck implemented
a plan to increase vaccine production capacity over a three-phase period (construction: 2004–2012) to double production. The following constructional features were noted:
Modular execution: Efficient construction realized by the assembling of prefabricated modular units
One-team: Construction period shortened through highly cooperative work by 50 equipment manufacturers and 46 subcontractors
Six Sigma approach to commissioning, qualification, and validation: The Lean Six Sigma approach applied to CQV to cope with the challenges of large-scale facility construction and a very tight schedule
Tour members were permitted ample time to view the facilities. Through this, members recognized the merits of modular design, which included not only a shortened construction period but also easily cleanable flat walls.
BMS is a global biopharmaceutical company that is further transforming itself into a specialty company. Members were shown the R&D facility in Hopewell, New Jersey, as well as Building No. 17. In the R&D facility, the biomanufacturing line was viewed, as well as an investigational drug manufacturing process. Diverse areas of the campus were shown, including an animal facility. Office space and R&D facilities at Hopewell are being further expanded, and the site area is clean and well maintained. Tour members were again impressed by the funding ability of BMS as a global business enterprise in securing its future position in the industry.
Plant tour itinerary
Tuesday, September 13
Departed Tokyo for
Wednesday, September 14
Afternoon - Biogen,
Research Triangle Park, NC
Thursday, September 15
Morning: Merck, Research
Triangle Park, NC
Friday, September 16
Morning: BMS, Hopewell,
Saturday, September 17
Afternoon: ISPE Annual
ISPE 2016 Annual Meeting,
Thursday, September 22
Departed Atlanta for Tokyo
At the Affiliate’s Winter Meeting in December 2016, registrants were given an overview of the US plant tour through a highly visual poster display. To promote networking among Affiliate members, a reunion for participants from all U.S. plant tours is held every year. The joint reunion for participants in the 2008–2016 plant tours was held in Tokyo in February 2017.
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.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.