Chugai Pharma Manufacturing Co., Ltd. is a member of the Chugai Group and is responsible for manufacturing functions.
In this interview, we focus on FJ2, a synthesis API manufacturing facility for small and mid-size molecule drugs in which we were involved from the concept design.
FJ2 was awarded the 2023 Facility of the Year Awards by the International Society for Pharmaceutical Engineering (ISPE).

Company Information

Name	Chugai Pharma Manufacturing Co., Ltd
Establishment	May 2006
Capital	80 million yen
Representative	Kenji Kamada, President and Representative Director
Number of employees	1508 (as of December 31, 2021)
Business	Manufacture of pharmaceutical products

• 

  Daisuke Hirasawa

  Digital & Engineering Dept.
  SPECIALIST
  ENGNEERING

• 

  Kiminori Matsuura

  GROUP MANAGER
  MANUFACTURING GROUP 2

Positioning of the FJ2 Project

CM Plus

Congratulations on receiving the Facility of the Year Award from ISPE.
Although our assistance was limited to conceptual design, engineering company selection support, and on-site building structure and piping welding management support, we are delighted that the project we were involved in has been recognized internationally.
What is the positioning and significance of the FJ2 project for Chugai?

Hirasawa

Chugai’s strength is in biopharmaceuticals and antibody drugs, but we also position small and mid-size molecule drugs as one of our major pillars, and we decided to construct FJ2 as an important infrastructure to accelerate their development and increase their supply capacity. Please refer to the press release.
https://www.chugai-pharm.co.jp/english/news/detail/20190424170001_617.html?year=2019&category=

CM Plus

At the Fujieda plant, the construction of FJ1, then FJ2, and now FJ3 is underway.
At which phase of the development stage will the products handled in FJ2 be?

Hirasawa

FJ2 corresponds to the Phase 1 to 2 of clinical trials. Our major strategy is to manufacture products at Chugai consistently and in line with the clinical trial development phase; Phase 1~2 are for FJ1 and 2, and Phase 3 to early commercial products are for FJ3.
In addition, many of the drugs Chugai manufactures are highly active, and it is difficult to outsource manufacturing to outside CMOs, etc. This was also behind our decision that it would be advantageous in terms of further acceleration of development if we could consistently handle the manufacturing in-house.

CM Plus

Hence you make a strategic decision after considering the possibility of outsourcing, do you? The recent trend in pharmaceutical manufacturing is to outsource to CDMOs, but we understand that you are emphasizing the advantages of doing everything from development to manufacturing in-house.

Matsuura

Chugai’s development products have become very active, and outsourcing was almost impossible. Recently, original drug manufacturers have been outsourcing their development and manufacturing to CDMOs. The contract market is booming, but outsourcing the supply of APIs in the initial phase will still slow down the process. The earlier the initial phase is, the faster we can supply the drug substance if we manufacture it in-house.

CM Plus

That makes sense. So, you are aiming for a facility that can handle everything from development to actual production, including the FJ3 project that we are currently assisting with?

Hirasawa

Yes, FJ3 is positioned as a so-called launch plant that can handle initial commercial production.

Matsuura

We started construction of FJ1 around 2003, but 20 years have passed since then, and the quality of our development products has changed in the FJ2 project. The high potency I mentioned earlier and the need to cover small and mid-size molecule are now required, and FJ2 reflects these changes.

Hirasawa

When we were proceeding with the conceptual design of FJ2, few people knew anything about facility construction, and we were starting from a question “how can we proceed?”

CM Plus

Thank you for consulting with CM Plus on that occasion. Being involved in your important project during the conceptual design phase has been a pleasure.
We heard Mr. Hirasawa’s presentation at the recent seminar hosted by Business Engineering Corporation. A facility with a containment performance of 0.05㎍/m3 or less is a rarity, even on a global scale.

Hirasawa

Now that the project is completed, we can say that we have achieved it, but at the beginning of the project, many people thought it would be difficult.

CM Plus

At the beginning of the study, we also expressed our opinion that it would be difficult. We apologize for our rudeness and pay our respects to your company for clearing this challenging standard.
At the kick-off meeting for FJ2, nine years ago, Mr. Hirasawa explained the design concept of the containment facility, and we identified the tasks for each manufacturing process and considered appropriate containment measures for each task, and through repeated examination and verification, we were finally able to overcome the wall of 0.05μg/m3.

Hirasawa

The project had many difficulties, but we believe all sorted. As we mentioned at the seminar the other day, thoroughly examining the facilities in the early stages, when there is a high degree of flexibility is essential. we think the fact that we were able to work on the concept design with CM Plus, who had knowledge in the early stages and shared the same final goal, has led us to where we are today.

CM Plus

We are very glad to know that.

About ISPE’s Facility of the Year Awards

CM Plus

Talking about this facility, how did Chugai respond to receiving the Facility of the Year Awards from ISPE?

Matsuura

The response was beyond our expectations, including from companies related to the Chugai Group as a whole. We also received attention from within the company as well.

Hirasawa

We had more opportunities to make presentations after receiving the award, and I began to receive feedback from both inside and outside the company, even from people we didn’t know, such as, “This is a good project.”

CM Plus

How was the award ceremony?

Matsuura

The award ceremony was spectacular, and all the Chugai members seemed to feel a sense of accomplishment as they were honored as winners in front of about 500 people in attendance.

Hirasawa

As a Winner, we presented the FJ2 project to the participants during the conference, which was a valuable opportunity for us to communicate the project to the outside.

CM Plus

We heard that the presentation was excellent. We think it was an effective way for your company to communicate the FJ2 project to the outside. As a Japanese, we feel proud that Mr. Hirasawa was able to play an active role in a place that is attracting worldwide attention. We would like to see other Japanese projects challenge FOYA more aggressively, but there are still very few. We think it is partly because Japanese people are not good at appealing to the outside and partly because they don’t want to put information outside the company in the first place.

Matsuura

Indeed, plants of Japanese original drug manufacturers are rarely shown to the outside.
We assume that we are gradually changing how we show and present information to the outside.

Hirasawa

We were also fortunate to have a supervisor, a plant manager, and a department manager who understood our decision to entry the award. With their approval, we were able to actively submit more products.

CM Plus

This is Chugai’s corporate culture. As you have stated in your policy, you respect “employee initiative” and “taking on challenges”.

Hirasawa

We entered the competition with the understanding of the people around me, and at that point, I just wanted to keep it as a memento. We were deeply moved by the fact that the project was selected for the award, and what we had accomplished was conveyed to various people within the company. The reverberations spread like ripples spreading from a stone thrown into the water.

CM Plus

A single stone thrown into the water triggered a ripple of positive trends spreading further within the company and beyond.

Why you invited a Construction Management (CM) Company? And why that was CM Plus?

CM Plus

Could you please explain why you invited a CM company in the FJ2 project?

Hirasawa

One of our objectives was to ensure transparency. The idea was to place the order transparently, which would allow us to explain the project to shareholders and other interested parties. If we entrusted the project to a particular order, it would not be fair to our clients. To ensure transparency that can be explained, we thought it necessary to obtain quotes from other companies and make a selection.

CM Plus

Recently, we have seen an increase in customers who think this way in Japan. They are required to be accountable to internal and external parties. Suppose the conventional method of placing a lump-sum order from design to construction with a single company’s particular order is used. In that case, accountability cannot be fulfilled, so they have established a policy of placing orders after creating a competitive environment and making selections. They will likely use us, CM Plus, in that case.

Hirasawa

The FJ2 project was the first large-scale construction of an API manufacturing building since FJ1, completed about 20 years ago, so we hired a consulting company to facilitate the initial phase.

Matsuura

We still remember that at the time, we could not estimate how much the project would cost.

CM Plus

We are honored to work with you. We are very good at taking a project from its initial formless state, giving it shape, and narrowing down the plan while presenting a rough cost estimate.
What made you choose CM Plus from among many CM companies?

Hirasawa

We selected CM Plus because of its strengths in both buildings and process equipment.

Matsuura

At the time, we searched the Internet for CM companies, but only CM Plus offered services that included production equipment.

CM Plus

Thank you very much. We are proud of the fact that we can provide design services including process equipment. There are many architectural design firms and CM companies in Japan, but most of them are architectural companies. We believe that we are a unique design firm and CM firm that has the DNA of engineering and can design facilities centered on process equipment.

CM Plus

How was it hiring CM Plus? We would like to have your frankly opinion about our strengths and an area for improved.

Hirasawa

We feel that the level of responsibility and the results they delivered on the work we requested for the FJ2 project are worthy of recognition. We also appreciated the flexible and timely response to our project requirements during the work period. You contributed to the stable progress of the project.
To proceed with the project, we had to involve many people. Where our information was not sufficient to gain understanding, you provided us with a wealth of information, which enabled us to proceed quickly and with a sense of unity among all parties involved.

Matsuura

We are glad that you were involved in the project from the initial stages to the inspection at the time of construction and that you could confirm and make various proposals based on your understanding of the FJ2 concept. Since you were involved in the project from the concept design stage, you knew the concept and background of FJ2, so you could chatter and give us precise support at the points where we needed it.

CM Plus

Thank you for your appreciation. We are delighted that we were able to help you execute your project.

CM Plus

Thank you for the opportunity to interview you today.

Plot 1: About the FOYA award trophy.

CM Plus

After receiving the trophy at the awards ceremony…

Plot 2:

Note: The information included in the interview article is as of the time of the interview.