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Shimadzu Diagnostics: pioneering development in regenerative medicine and microbial testing

Interview - June 10, 2023

Through its microbial testing kits and regenerative medicine solutions, Shimadzu Diagnostics is helping to tackle the greatest global health challenges.

 

TOKUYA ONO, PRESIDENT OF SHIMADZU DIAGNOSTICS CORPORATION (FORMER NISSUI PHARMACEUTICAL CO., LTD.)
TOKUYA ONO | PRESIDENT OF SHIMADZU DIAGNOSTICS CORPORATION (FORMER NISSUI PHARMACEUTICAL CO., LTD.)

Editor’s Note: From November 2022, Nissui Pharmaceutical became a 100% subsidiary of “Shimadzu Corporation” and, from April 2023, changed its company name to “Shimadzu Diagnostics Corporation”.

Nissui Pharmaceutical was established in 1935 in Odawara City, Kanagawa, as a business that assisted local fisheries. Can you run us through the genesis of Nissui Pharmaceutical and how it evolved alongside the Japanese medical field?

The Japanese pharmaceutical sector has similar roots to the Chinese one. Our medical tradition has been based on herbal medicine, which utilizes live agents as well as raw and organic ingredients. Historically speaking, Japan’s medical research revolved around discovering new ways to use natural ingredients for medicinal purposes. I think that is how most pharmaceutical companies started, including ours.

Our company was originally named Nippon Suisan. In the years following its establishment, Nippon Suisan produced marine ingredients from fisheries. Through time, we began to research how aquatic products could be used for medicinal and pharmaceutical purposes. For example, we developed medical products taken from whales. Even though the commercial utilization of whale byproducts has now become a sensitive topic, especially in the West, the founding principle for this initiative was very noble: our goal was to maximize the use of the animal so that nothing would be wasted. To this day, whales’ whiskers are used in writing instruments, such as brushes. Our company saw potential in deriving new drugs and medicines from whale liver, thus marking our entry into the medical field. Japan is a country with very limited natural resources. As such, companies such as ours had to find techniques to most efficiently use the few natural resources that were available. I am not an expert in this, but I can say with confidence that most of Japan’s medical companies prior to World War II had this mindset.

Since the Meiji Era, the Japanese have been passionate about learning from experts and expanding their knowledge in fields they are unacquainted with. Japanese people do not hesitate to approach and learn from others who are highly skilled and competent. This strong curiosity has become part of the Japanese character and has played a central role in the development of different industries and sciences, including medicine.

Japanese professionals spent decades learning about Western advancements in science and medicine. The technique of pasteurization, for example, was imported to Japan. Once the technique was understood, Japanese engineers and professionals would then adapt it to the local requirements. This sense of curiosity and this desire to learn without respite to create something new is part of Japan’s ethos.  

 

The Japanese medical sector is often criticized for having a burdensome regulatory framework that is supposedly three to five years slower than that of the West. Nevertheless, since 2012 and the Shinzo Abe administration, there have been significant reforms, including the PMDA & Safety Act as well as the Sakigake Designation System. What is your assessment of Japan’s regulatory framework today?

That is a great topic of discussion. The Japanese medical sector is truly interesting because it works under a government-backed universal healthcare system, meaning that everyone has access to public health insurance. Because of the government’s direct involvement, our approach to treatment and product commercialization is unique. In Japan, the elderly must personally cover around 10% of their medical expenses while younger generations usually cover around 30%. The rest is covered by public finances and subsidized by the government. Since Japan has an aging population, government insurance spending and medical fees are surging and will continue to in the years to come.

To navigate this complex system, companies must understand the government’s budget and taxation framework while complying with various regulations. For this system to be successful, a strong rapport between the private and public sectors is required. In November, there was an interesting seminar about finding ways to remain innovative despite the strict budget allocations set forth by the public sector. This conference was organized and attended both by government officials and pharmaceutical companies.

At Nissui Pharma, one of our goals is to help improve the regulatory framework and overall ecosystem of the clinical reagent industry. On top of my position at Nissui Pharma, I am also the president of Japan's Association of Clinical Reagents. At the association, we hold frequent deliberations and maintain close ties with our US and European counterparts, such as the AMDD and EBC, with whom we share common interests.

The goal of the association is to make the Japanese clinical reagent ecosystem more suitable for innovation in advanced pharmaceuticals, drugs, and treatment possibilities. Everyone is fully cognizant of the reforms required to improve the environment. Improving the regulatory framework has been on the government's radar since the Abe administration, which passed reforms to speed up the approval system. As a result, it is much faster today than it used to be. The timeframe for approval was effectively cut down by a third. Most people within the industry will agree that things are moving in the right direction.

 

To face increasing insurance costs, the Government and medical sector have made the development of ‘preventive medicine’ a priority. Within that realm, the utilization of digital technologies to deliver personalized healthcare holds many promises. What digital technologies is Nissui Pharma deploying?

I will be answering this question from the perspective of our product: Raisus S4. Because of our background working with whale liver, we have developed strong leadership in the microbial sector. Food safety is greatly linked to the treatment of different diseases. The spread of diseases and epidemics is closely connected with food consumption and conservation.

Regarding Raisus S4 and our work in the microbiological area of diagnostic reagents for clinical testing: a rising global problem with bacteria is their increased resistance to antibiotics. Medical specialists involved in disease and epidemics think that the tendency of people dying from cancer is less important than that of those who die from antibiotic-resistant bacteria. Raisus S4 is a fully automated rapid bacteria identification and anti-microbial susceptibility testing instrument using digital detection technology.  It returns the result report at least within 3 hours. To give you an example of the risk associated with this global problem: the only weapon we have against tuberculosis is vancomycin. What would happen if that treatment no longer worked? To tackle this global issue, tracing where the resistant strains come from and identifying the root causes for resistance is of paramount importance.

Continuing to feed poultry and various livestock with antibiotics only makes the situation worse because the amount of resistant bacteria increases. The ultimate fear is that as more and more resistant strains appear, we will become susceptible to diseases because we will no longer have the necessary tools to fight them. We also share this concern with medical specialists.

To tackle the issue of antibiotic-resistant bacteria, the food production industry must work collaboratively with the medical sector and with research organizations. We have tie-ups with academic institutions and collaborative projects aimed at finding the origin of resistant strains.

Since antibiotics require a prescription in Japan, the amount of antibiotic-resistant bacteria is less than in other parts of the world. However, in this global age where there is so much movement from one country to another, constant monitoring of the situation is necessary. Oftentimes with infectious diseases, unless the doctors are infected, it is hard to detect the root cause. There is an increasing understanding that the best way to fight infectious diseases is through regular healthcare and maintaining a strong immune system. Another strategy is to better control and monitor the movement of food products. Food products are often produced by a global enterprise in which something derived in one place is processed in another country, then comes into the country through different routes. By its global nature, food production is intricately connected with the issue of containing infectious diseases.

 

Nissui Pharmaceutical provides CompactDry, a dry medium used for coliform counting that requires no preparation for use. Why is CompactDry better than other similar products? What applications does it have?

CompactDry is an amazing product. It has a long lifespan and can be delivered in both humid and dry environments. In comparison to other culture media which require chilling between 2 °C and 5 °C for safe transport, CompactDry is a dry medium and can be transported without such precautions.

CompactDry, for example, can detect listeria, a type of strain of bacteria that causes food poisoning. By its ease of use, CompactDry allows us to garner an important amount of data that we can then utilize to detect the origin of bacteria strains and the potential causes for food poisoning, thus enabling us to create a safer and more hygienic environment for food products worldwide. Another strength of CompactDry is that it is a ready-to-use culture media that can be adapted to the needs of the users. The WHO has identified infant diarrhea, cholera, digestive tract complication in children, and contaminated water as core medical issues. Our microbial detection kits provide solutions to each of those problems and are therefore marketed globally. This product has so much potential and is self-explanatory that the products promote them by themselves! As is often the case, when people from other industries learn about CompactDry, they realize that it can be used for applications unrelated to the medical and food production fields.



We hope to extensively promote CompactDry as a microbial detection kit that can be used anywhere and at any time. Thanks to its ease of use and transport, CompactDry is a perfect solution for developing countries and remote areas with poor infrastructure and limited cold storage.

To give you an example of CompactDry’s potential: as part of its CSR initiative, the Yamaha Boating Company ensures that the drinking water found in the villages where its boats are exported is clean. To make sure that Yamaha’s boats do not create a toxic environment, Yamaha employees hand out our detection kits! Within minutes, the local people can then check the safety of the water. What’s more, they can keep our kits for long periods. Because our product does not need to be refrigerated, it can be stored at normal temperatures, including in humid environments, and will remain effective for two years. Moreover, by using our BactLAB system, colony counting can be done through a smartphone camera, making the test results easy to access, read and understand.

Another area as an extension of our core business is allergen testing where we provide an important solution to ensure the safe operation of production facilities and processing plants. For example, when nuts are used in a production line that also processes other food products, it is important to make sure that the machinery is conveniently washed so that it may not cause a problem to consumers with a nut allergy. The motivation behind our allergen test is to ascertain the health and safety of people around the world.

Looking at the future, the two major fields we are heading toward are regenerative medicine and programmable medical devices, including wearables. Not only can these two fields greatly enhance the quality of life of people, but they can also advance preventative healthcare.

 

Nissui Pharma offers cell culture medium and tests for regenerative medicine. This includes HYDROX, a three-dimensional cell culture substrate that allows the growth of different types of cells. Why did you decide to move into cell culture for regenerative medicine? What advantages does your past as a provider of clinical and industrial diagnostics bring to your cell culture and regenerative medicine business?

Our cell culture business traces back to 1967, around the time I was born. Actually, we were the first in the Japanese cell-culture business to commercialize a culture media.  That product is now utilized as the core, classical methodology of culture media in the regenerative medicine sector. In the past, vulva and serum were utilized for the preparation of culture media and cell cultures. However, the risk of creating animal-derived infectious diseases made those types of culture undesirable.

Since then, we have developed high-quality media used in regenerative medicine, such as our MSF-BM. Because regenerative medicine is part of the national strategy of countries, we cannot disclose certain information to the public. Although we may not want to disclose our industrial secrets, we are required by the policies in place to transparently share information with regulators. Cell culture production is in a tense business environment because trade secrets must be shared with regulators but can easily be copied by other companies.

In Japan’s regenerative medicine sector, there is a united push to promote iPS cells, a market that Ajinomoto dominates. Apart from iPS cells, stem cell research is quite important. Despite the area of stem cell research being extremely wide, finding viable and practical solutions is a narrow and slow process.

Since the cell culture business, particularly culture media and reagents, is part of our rich know-how, our strategy is to provide custom-made solutions in this field. We believe that our efforts in the cell-culture business will enable Japanese firms to go beyond the research level and start to commercialize products on the market.

If the industry itself continues to expand, then the use of cell cultures will expand as well. We are not necessarily interested in the end product of regenerative medicine. Rather, our focus is finding the best media for cell cultures.

Regenerative medicine involves extracting and introducing cells from the human body.  In order to create the optimal environment for cells to be safely taken from and then reintroduced into the human body, various tests have to be performed. Having our cell cultures utilized in that process is one of our main targets. To a large extent, these cell cultures can be considered door openers that will allow us to enter new realms. If our clients can find new treatments by using our products, we will mutually flourish.

Another area in regenerative medicine we are pursuing is safety testing. We have already introduced PCR based Mycoplasma testing kits (Myco-finder) and Virus testing kits (Viru-finder). As previously mentioned, Japan's approval system is slower than that of Europe or America. To get around that hurdle, we have international subsidiaries and offices located where our products are sold. Products such as Myco-finder and Viru-finder were approved in Japan, however, the approval processes took a rather long time. We started to think a business model to launch those types of products in Europe and/or America would be more appropriate, and then to export them back to Japan. Fortunately, or unfortunately, however, such bureaucracy has greatly changed since COVID, as Japan has become more aware of the need to step up its game. Now we think we need to gain approval from all three markets, namely, domestic, Europe, and America promptly.

The second big push we are making is in programmable medical devices, such as wearables, which we predict will grow exponentially in the years to come. We do not have know-how in this area because we have not been involved in manufacturing medical devices. One of the reasons we decided to pursue corporate integration with Shimadzu Corporation is that we saw the need to expand in this field. To put it simply, we have medical knowledge and advanced software, but we lack medical device manufacturing experience, which Shimadzu has.

From November 2022, Nissui Pharmaceutical had become a 100% subsidiary of “Shimadzu Corporation” and, from April 2023, changed its company name to “Shimadzu Diagnostics Corporation”.

Our connection with Shimadzu started when we began selling their PCR kits several years ago. There was a need for their test kits to be utilized on a massive scale to check that food products were not contaminated by the Norovirus. Shimadzu supported us by taking charge of rolling out the industrial agents needed for that detection. They also worked with us, a couple of years ago, in the production and distribution of PCR tests for COVID. In the future, we will provide our expertise in testing reagents and Shimadzu will provide its strength in Liquid Chromatograph-Mass (LC-MS) and Gas Chromatograph-Mass (GC-MS).

Japan uses European and Western machinery, including Roche and Abbot, in the immunological sector, so Shimadzu is currently trying to become a domestic manufacturer. Since they are machine manufacturers, they have been able to systematize their data. We are sincerely excited to further cooperate with Shimadzu and to take a big step forward into biopharmaceuticals and wearables. 

 

Can you tell us more about your international strategy? What are some of the key markets that you would like to expand into? 

Our CompactDry and food safety products enjoy strong exports. Looking at the future, we will create more synergies with Shimadzu. Shimadzu’s strong suit is in chromatography, which is used to decontaminate groundwater and soil pollutants. We want to develop a collaborative business model in which Shimadzu provides our CompactDry kits and its related products in the same markets where it provides chromatography instruments. Similarly, we want to introduce Shimadzu’s chromatography instruments in places where we sell our kits. By combining our expertise, we can deliver a more complete service and package to our clients.

On the other hand, in the clinical area, our quality control serums for clinical testing are widely praised and used in Japan. We do not only seek to expand that product but also to strengthen its global supply. As the supplier of this product, we are keeping a 3rd party position in Japan. This is because we purely provide our quality control serum as a neutral 3rd party and are not biased to sell our clinical testing system at the same time. That is a strength we can leverage on. We are not necessarily interested in exporting more testing agents overseas, rather, we want to become a globally known supplier of quality control serums. We plan to take advantage of Shimadzu’s worldwide subsidiaries as a channel to expand our serum production.

In all honesty, I do not consider myself to be a smart, tech-driven entrepreneur. That being said, I sincerely believe in the groundbreaking potential of digital technologies. As part of my management philosophy, I believe that the utilization of web/online tools will allow us to become true innovators. I often promote this view with my staff and I have set the development of digital tools a key part of our mid-term strategy.

Innovation is not something that we can do in isolation. As such, we seek to expand our business lines and partnerships. To become an innovator, we must achieve three developments: the first is to create a universal digital platform that can be used across all of our businesses. One such platform is the BactLAB and Ni-QCS (Nissui-Pharmaceutical Quality Control System) which makes use of the software we developed. By integrating all the data from our business channels into a single database, we can find cross-channel solutions applicable to all of our business areas, whether it is food safety or cell media. The second target is to venture into biopharmaceuticals and programmable medical devices. To achieve that venture, partnering with a manufacturer of medical devices was primordial. Through our integration with Shimadzu, we have successfully made that requirement a reality. The third action is to further develop NeyeS, an open innovation program we are promoting among our engineers.

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