New Paths & Old in the Japan Affiliate’s US Plant Tour

In conjunction with the 2018 ISPE Annual Meeting & Expo in November in Philadelphia, the ISPE Japan Affiliate held its annual pharmaceutical plant tour. The tour extended over four days from 29 October to 1 November. The group visited four US plants—three in California and one in Indiana.

A total of 20 professionals from across Japan participated, including Affiliate Treasurer Hiroshi Sakai, Head of Secretariat Akihiro Matsuki, and Adjunct Director Michael J. Lucey, who jointly led the Organizing Committee of Affiliate Board Members. The tour team included eight members from pharmaceutical companies, eight from engineering/construction companies, and four from equipment manufacturers.

The group visited Shire in Los Angeles; Boehringer Ingelheim in Fremont, California; Novartis in San Carlos, California; and Eli Lilly in Indianapolis. Then they traveled to Philadelphia to attend the ISPE Annual Meeting & Expo. The following are highlights from the individual plant tours.

Shire

The 2018 tour team’s first visit was the Shire Los Angeles manufacturing plant. Tour members saw the new QC laboratory as well as the Building 8 purification manufacturing facility, which were selected as category winners of the ISPE 2018 Facility of the Year Award (FOYA) in the two categories of “Operational Excellence” and “Facility Integration & Overall,” respectively. The newly constructed QC lab functions as a control lab for next-generation plasma-derived therapy, for which global demand is increasing. The design achieved an open and efficient development environment by incorporating a Lean process ow and an improved work environment for the employees. Building Information Modeling (BIM) was used to design the Building 8 manufacturing facility. The philosophy is that maintainability and operability should be taken into consideration at all times. An optimal facility has been realized through a real-time review during construction with feedback from designers and the manufacturing team to the facility design. At the 2018 Annual ISPE meeting on 6 November, it was announced that Shire’s Los Angeles Building 8 manufacturing facility was the Overall Winner for the 2018 FOYA.

Boehringer Ingelheim

The team next visited the Boehringer Ingelheim biomedicine manufacturing facility in Fremont, California. Following the overview presentation, the team saw the production line and this was highlighted by the host’s professionals during the facility walkdown, which comprises six processes: cell culture, harvesting, initial purification, final purification/formulation, filling, and warehousing, with two lines dedicated to the first four processes. A full and unobstructed view of the production line from the visitor’s corridor is a major advantage, enabled by the glassed-in design. With the adoption of mobile single-use equipment, the highly flexible character of the facilities was recognized by all. At the time of the visit, an additional 12 kl SUS culture tank was being installed. At the close of the tour, a networking reception was provided by host company representatives, which itself offered a further opportunity for quality questions and answers. The lasting impression left with the visitors is the host’s strong passion for biomedicine manufacturing.

Novartis

Novartis’s Technical Research and Development (TRD) facility and production facility is in San Carlos, California. The production line for the aminoglycoside antibiotic “TOBI” (tobramycin) is composed of a solution adjustment unit, spray dryer, homogenizer, powder loader, and other units. High-potency active pharmaceutical products are manufactured and isolators are adopted for the powder loader and inspection unit. The TRD facility and the commercial manufacturing facility are laid out at the same site. It was clearly noted by the visiting team that this made for good communication. Moreover, Novartis has demonstrated its own initiatives in all design processes, from the characteristics of pharmaceutical products to the design of production equipment and inhalers. The host company takes great pride in its products.

Eli Lilly

The tour team’s final stop was Eli Lilly’s continuous manufacturing facility in Indianapolis, the 2017 ISPE FOYA Winner. Members observed the operation of the continuous direct compression process and small molecule production line. The direct compression process is the simplest process for tablet manufacturing. Eli Lilly uses simulation techniques and experimental approaches in evaluating fluctuating factors, and their quality management strategy has been established using process analytical technology tools and modeling techniques. Given the interest in Japan in all aspects of continuous manufacturing, this visit was a timely one, permitting the opportunity for an enhanced understanding of Eli Lilly’s approaches to quality management.

Conclusion

The tour was realized through the cooperation of the host plants as well as friends of the Japan Affiliate in the ISPE organization. For this, the authors and the Affiliate wish to express sincere gratitude.

On a lighter note, and maximizing the opportunity of being in the US, visits were made in free time available to a Napa Valley winery and the Indianapolis 500 Race Course and Museum. All of this made for a highly interesting time, as well as being most educational for all.

For a further widening of the network of members in Japan, the Affiliate holds a reunion every year for all participants in the US pharmaceutical plant tour over the many years of its history and displays the tour in poster form at the Winter Meeting in December.