A virus vector CDMO born from the Institute for Virus Research in Taiwan
First of all, please introduce the company.
Mr. Yuan: Our roots date back to the Institute for Virus Research, which was established by the Bioscience Technology Development Center, which was funded by the Taiwan government. In 2016, we became independent CRO from Taiwan, specializing in biological safety testing and quality testing. Our current main businesses are the CDMO business, which develops and manufactures viral vectors for cell therapy and gene therapy products, as well as test services for biosafety tests and product shipment tests for gene therapy products, vaccines, and biological products. Headquartered in New Taipei, Taiwan, it also owns GMP facilities in New Taipei and Xinzhu provinces for research-level to large-scale commercial production.
In the contract manufacturing of viral vectors, we provide a one-stop service that completes everything from preclinical research levels, clinical trial levels, and commercial levels. The types of viruses to be handled are rench virus, retrovirus, adeno accompanying virus and adenovirus. Most of our customers are Taiwanese companies, but Japanese customers account for about 30% of the total.
Mitsui Link Lab Kashiwa-no-ha 1
A Japanese subsidiary (TFBS BIOSCIENCE GK) has also been established.
Mr. Yuan: Japan is an advanced destination for regenerative medicine and genetic medicine, and is an important market for us. In the development of biopharmaceuticals, it is very important to find and resolve various issues that may be problematic in the early stages of development and later stages in the development process for efficient development. Therefore, in an environment where discussions can be held with Japanese companies and researchers from an early stage of development, we decided to establish a base in Japan as well. We have established partner relationships with Mediridge Co., Ltd. and Teijin Co., Ltd. Last year, the three companies concluded an agreement to form a business alliance on the supply of viral vectors and plasmids used in the manufacture and development of regenerative medicine products with gene introduction.
The role of Kashiwa-no-ha R&D Lab is "to play an early stage of research and development in collaboration with Japanese researchers."
Please tell us about your company's strengths.
Mr. Huang: We have more than 10 years of development experience and experience, including the days of the Institute for Virus Research at our predecessor, Bioscience Technology Development Center. In addition, we have a system in Taiwan that can consistently handle everything from R&D to animal testing to product manufacturing and quality testing. As for manufacturing facilities, we have also obtained international certifications such as FDA (Food and Drug Administration) certification, so products developed and manufactured by our company can be deployed in the United States. In addition, the report of the work entrusted by our customers in Japan was reviewed by PMDA in Japan to provide appropriate support for the needs of conducting clinical trials.
Recently, Taiwan is also active in the biotechnology world. What is the difference between Japan and Taiwan?
Mr. Yuan: Taiwan companies are also very active in expanding overseas. Taiwan has not ratified the Cartahenna Convention (a law to prevent adverse effects on biodiversity by taking regulatory measures for the use of genetically modified organisms, etc.), so it is also characterized by a high degree of freedom of research. In particular, the ability of highly flexible research at the early stage of development is an advantage of Taiwan, which can shorten the initial development and manufacturing cycle from several months to one year.
On the other hand, Taiwan is a smaller island country than Japan, so if you do not enter overseas markets, Taiwan alone will not succeed in the biopharmaceutical business. Recently, Taiwanese companies, mainly in the semiconductor industry, have been expanding into Japan, but the world of biopharmaceuticals is still in the future.
For the first time in Japan, "I was helped by the support of Mitsui Link Lab."
What is the role of the newly established Kashiwa-no-ha R&D Lab?
Mr. Yuan: The aim of opening the Kashiwa-no-ha R&D Lab is to work with Japanese companies and researchers from the early stages of development. Specifically, Kashiwa-no-ha R&D Lab will be responsible for early R&D, and Taiwan will be responsible for late development and actual production, which will require further scale-up.
What made you know about Mitsui Link Lab Kashiwa-no-ha 1?
Mr. Yuan: Our partner company, Teijin Co., Ltd., has a base for the CDMO business of regenerative medicine and other products at Mitsui Link Lab Kashiwa-no-ha 1. In the Kashiwa-no-ha area, there were many academia and research institutions such as the National Cancer Center East Hospital and the Kashiwa Campus of the University of Tokyo, and it was also attractive because it was close to the University of Tsukuba. It has good transportation and good access to Tokyo.
Mr. Huang: I am very grateful that Mitsui Link Lab will provide opportunities for discussion with the professors of the National Cancer Center. In the future, I hope that Mitsui Link Lab will have the opportunity to exchange opinions with researchers from the Kanto region who are active in the fields of regenerative medicine and gene medicine.
What kind of impression did you have when you actually started working at Kashiwa-no-ha Lab?
Mr. Yuan: At first, I was surprised that the operation rules are strict. However, it is good that the operational rules are strict, and we only adhere to the rules, so we had a good impression. It's also good that there are many companies, including competitors, and it's easy to contact. On the same floor as us, there is a company that speaks casually.
Mr. Huang: In the case of an overseas company like us, even if you open a lab in Japan, you don't know at first. In that regard, Mitsui Link Lab provided a variety of support, so I was very encouraging. Without the cooperation of Mitsui Link Lab, we would not have been able to start the operation of the lab as soon as possible. In that respect, I think it's very wonderful.
Please tell us what you want to achieve in the future through Mitsui Link Lab Kashiwa-no-ha 1.
Mr. Ryu: It has not been a year since I moved in yet, so I am still doing my best to know everyone, but in the future I will further deepen exchanges with other residents of Mitsui Link Lab Kashiwa-no-ha 1 I want to go.
Mr. Yuan: Kashiwa-no-ha R&D Lab is our first overseas lab, and the scale is not yet large. In the future, I would like to take on the challenge of collaboration between industry, academia and government, further expand the business in Japan, and expand the scale of the lab through business expansion.
