Becoming Media Independent for Advanced Bioindustries...'Chemical Media' is Worth the Challenge 

Media account for a high percentage of biopharmaceutical production costs

Independence of media for advanced biopharmaceuticals such as gene and cell therapies is a challenge worth pursuing.

Xcell Therapeutics challenges the global market by developing serum-free chemotactic media

Antibody drug media market led by Lonza, Cyclone, and Thermo

Vollmann to lead the media market for advanced biopharmaceuticals

Media is the 'food' for cells. The antibody drugs of Celltrion and Samsung Bioepis, which are leading the biosimilar market not only in Korea but also overseas, are also produced using animal cells. In this biopharmaceutical market, media is an essential material.

An industry insider with experience in producing biosimilars in Korea said, "When we were producing the first biosimilars, media was a very important material, accounting for about half of the cost." He added, "Although the cost structure has improved a lot now, there was a situation where we had to unilaterally adjust to the price set by foreign companies (because we had no choice) because we relied on foreign companies for all the media."

Lonza, Hyclone, and Thermo are the main suppliers of media for biopharmaceuticals, including antibodies and recombinant proteins, and the biopharmaceutical media market is worth about $143.5 billion (KRW 159.35 trillion). The market for antibody drug media is dominated by these large multinational companies, making it difficult for startups to enter the market.

On the other hand, media for advanced biopharmaceuticals, such as gene and cell therapies, tissue engineering products, and convergence therapies, do not yet have a major player leading the market. This is why it is worthwhile for domestic companies to take on the challenge of self-reliance in media for advanced biopharmaceuticals. Currently, representative companies that produce serum-free media for advanced biopharmaceuticals include Fujifilm in Japan and Xcell Therapeutics among domestic companies.

This market is also growing at a rapid pace as the number of advanced biopharmaceuticals increases. The market for media for advanced biopharmaceuticals is valued at 9.7 billion won ($10.7 trillion), with an average annual growth rate of about 40%.

An industry insider said, "The market for protein-based media such as antibody drugs has a lot of technological disclosures, so in the current market situation, it is driven by economies of scale rather than technology," adding, "This makes it difficult for domestic SMEs to compete on price."

"The market for media for advanced biopharmaceuticals, which does not yet have a clear major player, is expected to grow in size in the next 10 to 20 years," he said, adding that the importance of producing media for human cells will be even greater.

Development of chemical composition media required for homogeneity and easy traceability of raw materials

There are three types of media: fetal bovine serum (FBS), serum-free, and chemical formulations. Currently, fetal bovine serum medium (FBS) is not widely used industrially because it contains animal-derived substances and is difficult to collect from animal blood, but it is used in some laboratories.

Serum-free media offer improved safety compared to FBS, and while they do contain some animal-derived substances, they also contain human-derived extracts. However, serum-free media also have limitations in bulk supply and homogenization, as well as difficulties in tracing raw materials.

"FBS is already being withdrawn from the global market due to ethical issues related to the collection of blood from live bovine fetuses," said an industry insider, "and is rarely used industrially." "Serum-free media, which has improved some of the safety issues of FBS, also has the limitation that not all substances inherently contained in it can be analyzed by modern scientific technology," he explained.

To overcome the limitations of FBS and serum-free media, chemical composition media have emerged. They contain recombinant proteins and synthetics and do not contain animal-derived substances. Not only are they safe, but they can be produced in large quantities once a production system is in place. They are also easy to trace back to the source because they contain only identified ingredients.

"Chemical composition media are easy to industrialize because all components can be specified," said an industry expert. "In fact, antibody drugs have been able to be industrialized since the use of chemical composition media in FBS." He added, "With the development of chemical composition media technology, the antibody drug field has entered the stage of full-scale industrialization."

Currently, companies that have successfully developed chemical composition media for advanced biopharmaceuticals include Japan's AJINOMOTO and Korea's Xcell Therapeutics. In addition, Germany's Sartorius, which supplies various biomaterials to Celltrion and Samsung Bioepis, is entering the liquid media market by acquiring a stake in Israeli cell culture media specialist Biological Industry for 45 million euros (about 60 billion won). Earlier, Fujifilm, which has also entered the field of advanced biopharmaceutical media, acquired U.S. cell culture media specialist Irvine Scientific in 2018 for $80 million (about 87 billion won).

 The issue of media independence is how researchers view domestic media

Need for a foundation for domestic media to be utilized by companies and research institutes

In the field of advanced biopharmaceuticals, what is most needed for chemical composition medium independence is the awareness of the researchers who develop such drugs. In an environment where even a small condition can change the outcome of an experiment, it is not easy to switch from conventional media to media developed by domestic companies.

A Korean developer of advanced biopharmaceuticals using serum-free media said, "I agree that we should ultimately go to chemically formulated media, but I doubt that chemically formulated media will perform as well as conventional media." The developer added, "If a domestic company develops media, I think we will prioritize the idea that we should take a closer look at it in terms of media performance and securing permit-related data, including GMP."

In fact, even if a domestic company develops a medium technology that meets the standards of regulatory authorities such as GMP, it will be a long way to self-reliance if development companies and research institutes do not use the medium.

The Joint Cooperation Council for Bio Small Scale Enterprises, which was launched in September last year, focused on small scale enterprises that can be supplied to Celltrion and Samsung Bioepis as its first priority to achieve self-reliance. This year, we are also making preparations for the self-reliance of small-scale manufacturing for advanced biopharmaceuticals beyond conventional antibody drugs. The Ministry of Health and Welfare has passed a preliminary feasibility study for the project.

In addition, Xcell Therapeutics, which started early in the development of chemical composition media in Korea, received a lot of support from the Ministry of Trade, Industry and Energy, the Ministry of SMEs and Startups, and the Ministry of Health and Welfare. 

Apart from the ministry's localization policy, the government has been establishing various policies to revitalize the bio industry since the 'Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals' was fully implemented in August last year. The Ministry of Health and Welfare is taking the lead on issues related to advanced regenerative medicine, and the Ministry of Trade, Industry and Energy on issues related to advanced biopharmaceuticals.

In addition, the "Strategy for Promoting Bio Industry Commercialization and Regional-based Advancement," released jointly by the relevant ministries in November last year, contains various contents to foster the bio sector as an "industry. In the report, media and bioreactors are presented as key small-scale self-sufficiency targets. Currently, the Ministry of Trade, Industry and Energy is planning the 'Advanced Bio Next Generation Full-Cycle Production System Technology Development Project'.

An industry insider said, "In the end, solidarity with large companies is very important to achieve self-reliance for the bio industry in Korea," adding, "Just like subsidies for electric vehicles, there should be more active government support measures, such as subsidizing companies using domestic small-scale bioreactors."

Source : Hit News (http://www.hitnews.co.kr)