Successful development of a safe cell culture medium...and requests from overseas 

-Liberal Arts CEO leverages government support to take his business from concept to commercialization

-Global media market to grow 7x in 10 years...securing cell proliferation-based technology is key

Cellular therapies, which utilize living cells for treatment, have been recognized as the next generation of biopharmaceuticals. They have the potential to treat intractable diseases such as cancer, neurodegenerative diseases, and genetic diseases by providing more fundamental treatment than existing therapies. 

However, cell therapies have faced challenges in R&D, commercialization, and ethical issues. In order to develop a cell therapy, you first need a "medium" to grow the cells that will become the therapeutic material. The best source for this medium is human fetal serum, which has been difficult to collect due to ethical and technical limitations. For this reason, bovine fetal serum (bovine fetal) or serum-free (artificial) media have been used for cell therapy research.

The problem is that fetal serum, which utilizes animal serum, is prone to viral infections and supply instability, and serum-free (artificial) media, which contains human-derived substances, has the disadvantage of slow cell growth when cultured.

After 7-8 years of research, Lee paid attention to these limitations of fetal serum and artificial media, and succeeded in developing 'Selker' technology, a serum-free chemical composition medium with safe ingredients, and establishing a foundation for mass cell proliferation.

The serum-free medium is different from previous media in that it excludes animal-derived ingredients and is composed of only chemically identifiable ingredients. It consists of about 200 different components, including vitamins, amino acids, and more. One 500 ml bottle of cell culture medium containing these ingredients is enough to culture close to 800 million to 1 billion cells. 

In the industry, it is considered to be highly scarce as a technology that can be utilized for regenerative medical treatments such as stem cell therapy, gene therapy, and exosomes.

Read about trends in the pharma-bio industry

Lee's interest in cell therapy technology and production infrastructure began more than a decade ago when he graduated from Korea University's Department of Japanese and Korean Literature. After serving as the head of the management support team at Korea Yakult and then as the director of management strategy at its subsidiary, Medical Groupama, he led the entire healthcare business for more than two years and experienced firsthand the importance and development potential of regenerative medicine. This was possible because he experienced the rapidly changing trend of the pharmaceutical and biotechnology industry by working in a company based on bio-healthcare.

"As an employee from a liberal arts background, I was able to identify market trends and take a proactive stance in areas unrelated to my major, thanks to my unique ability to read industry trend changes," said Lee. "In particular, I was able to take the first steps in the business by reacting quickly and agilely to government policies and industry support directions."

From business model validation to commercialization with government support

Mr. Lee, who founded Excelsior Pharmaceuticals in 2015, has grown the company into a promising company with a total of 28 researchers, including two PhD researchers, in less than three years. The secret of growth was to actively utilize government support from business model validation to commercialization.

Before a technology can be commercialized, it is usually necessary to verify the feasibility of the technology and business model, analyze patents and establish strategies, and conduct research and development for technology commercialization. Then, it goes through a complex and multi-step process of securing a mass production base and building a system, acquiring various standards and certifications, and developing domestic and international commercialization.

Since its establishment in 2016, Excel Seraphytics has received government project support from the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, and the Korea Health Industry Promotion Agency to verify the feasibility of its business model. This is a result that would have cost at least 500 million won if it had been done privately.

Patent verification was also supported by the Korea Health Industry Promotion Agency, the Small and Medium Business Technology Information Agency, the Korea Intellectual Property Strategy Institute, and the Korea Intellectual Property Protection Agency.

No matter how excellent the original technology is, it is difficult to develop a business if there is no system in place to mass-produce products or if marketing and networking avenues are not in place.

In January this year, Excel Seraphytics received a budget of 5 billion won from the Ministry of Trade, Industry and Energy to support the development of mass production processes (project name: Industrial Technology Innovation Project). The company has also received funding for startup commercialization from the Korea Small and Medium Business Technology Information Agency and participated in China Link, a 2019 China membership program supported by the Korea International Trade Association and the Incheon Center for Creative Economy and Innovation, to solidify its network with global startups. 

"During the commercialization process, we received various support from government departments from A to Z, and were able to establish the substance of our business," said Lee. "Based on this, we received an investment of 4.6 billion won from Korea Investment Partners earlier this year, and we are receiving numerous requests from overseas, including Chinese stem cell therapy companies."

Key to establishing cell culture media facilities

Excelsior Pharmaceuticals plans to use the investment from Korea Investment Partners and others to build a GMP facility in Giheung, Gyeonggi Province. The facility will be capable of producing 150,000 bottles of 500ml cell culture media per year, and will begin operations this month.   

Securing cell proliferation-based technology is key to compete with global companies in the global medical market. The industry predicts that the global media market will grow nearly sevenfold from KRW 5 trillion in 2018 to KRW 35 trillion in 2028.

In September, Excelsior Pharmaceuticals purchased a site in Osong Advanced Medical Complex in Chungcheongbuk-do to build a cell culture medium production facility with the goal of completing the second plant in 2022.

Under the 'Special Act on Designation and Support of High-Tech Medical Complexes', the company can enjoy eight benefits, including priority examination of other patent applications when applying for patents related to medical research and development in the complex (Patent Act), allowing foreign doctors and dentists to practice medicine for the purpose of medical research and development (Medical Act), and greatly simplifying the process of medical device item approval and import approval by the Ministry of Food and Drug Safety (Medical Device Act).

"Regenerative medicine is an infrastructure that requires a mass production system, and the government's announcement of the National Vision for Biohealth last month contained a guiding agenda," said Lee. "If the government systematically frames and supports regulatory advancement and investment in infrastructure technology at the pan-ministerial level, we will be able to achieve remarkable results in the infrastructure barrenness." 

[Source] Korea Policy Briefing (www.korea.kr)

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