World's First 50-Liter Bioreactor Culture... How Did Dyusel Overtake Megakaryon?

Process Innovation Driven by "Industry DNA"
Scaling Up with Standard Equipment
Solving Supply-Demand Imbalances with Technology
Aiming for an IPO in 2028

The biggest challenge in commercializing artificial platelets is mass production. No matter how good the technology is, if you cannot secure sufficient volume, it will never reach patients. The reason Japan’s Megakaryon, which entered phase 1 clinical trials for artificial platelets earlier using four 10L bioreactors, has temporarily suspended its trial is that it failed to overcome this issue.

This is why Dyusel, the only artificial platelet developer in Korea, drew attention last month when it succeeded in producing artificial platelets using a 50L bioreactor. Founded in 2021 as a latecomer, it has now set a world-first record. Megakaryon is still stuck at the 45L stage. Dyusel CEO Lee Minwoo said in an interview with The Asia Business Daily at the company’s Pangyo office in Seongnam, Gyeonggi Province, on the 5th, “50L is not simply five times 10L,” stressing that it is “the minimum scale required for commercialization.”

Dyusel CEO Lee Minwoo is being interviewed by The Asia Business Daily at the Pangyo headquarters in Gyeonggi on the 5th. Reporter Kwak Minjae

"I refused advice to start from 10L"

The secret to rising to the global forefront just four years after its founding was a shift in thinking. CEO Lee and Chief Technology Officer (CTO) Kim Chihwa both came from GC Green Cross and have “industry DNA,” having experienced the full cycle of new drug development. Unlike competitors strong in mechanism research, they focused on scaling up from the very beginning.

When Dyusel was raising its Series B round, many advised the company to “start from 10L.” That was the path Megakaryon had taken. But Lee refused. He judged that if they followed the same path, they would remain perpetually behind. Megakaryon eventually changed course as well, moving to process development using a 45L bioreactor, but by then Dyusel was already racing toward a 50L target.

Dusel's incubator. Dusel

The technological approach was also different. Megakaryon used a custom-made bioreactor. To scale up, it has to redesign the bioreactor itself, which takes a long time. Dyusel, by contrast, chose a standard mass-production bioreactor from Sartorius in Germany. Instead of changing the equipment, it changed the culture conditions. Artificial platelets are produced by applying strong stress to megakaryocytes, their precursor cells. Dyusel optimized rotor rotation speed, flow, and gas conditions to achieve high yields even in standard bioreactors. Before introducing the 50L bioreactor, it completed simulations at 2L and 5L scales, and high-quality artificial platelets were obtained from the very first 50L run. Lee said, “Technology transfer is possible to any facility that has Sartorius equipment.” Unlike competitors tied to proprietary equipment, Dyusel has thus secured global scalability.

Targeting commercialization in 2029... first revenue in the second half of this year

Dyusel is developing three pipelines based on its artificial platelet platform “en-aPLT”: transfusion-use artificial platelets (DCB-101), an osteoarthritis treatment (DCB-103), and an advanced biomaterial, artificial platelet lysate (DCB-301).

The most advanced pipeline is the transfusion-use artificial platelet product. In collaboration with Samsung Medical Center, Dyusel is preparing a clinical trial for cancer patients with thrombocytopenia. The company plans to submit an investigational new drug (IND) application in the second half of 2027 and enter clinical trials in early 2028. Considering that Megakaryon is expected to re-enter clinical trials only in 2029, Dyusel is projected to be 1 to 2 years ahead.

Dyusel CEO Lee Minwoo is being interviewed by The Asia Business Daily at the company's Pangyo headquarters in Gyeonggi Province on the 5th. Photo by Kwak Minjae

The target for commercialization is 2029. While conventional new drugs take 1 to 2 years just for phase 1, artificial platelets only need to demonstrate equivalence with blood. Because the endpoint is clear, Dyusel expects to complete phase 1 in 3 to 6 months and phase 2 in 6 to 9 months. The company also anticipates the possibility of conditional approval after phase 2.

Immediate revenue will come from platelet lysate. This is an advanced biomaterial that can replace fetal bovine serum (FBS), which is used as a nutrient in cell culture, and it can be sold without clinical trials. In May last year, Dyusel signed a letter of intent (LOI) worth 2 million dollars (about 3 billion won) with PL BioScience in Germany, and it expects revenue to start in the second half of this year after signing a definitive agreement in April. Since PL BioScience presented “the world’s first artificial platelet lysate” at an international conference, competing companies have been reaching out with partnership offers.

"Creating a market that does not exist"

At the end of last year, Dyusel acquired a quasi-GMP (Good Manufacturing Practice) plant in Anyang, Gyeonggi Province, and began operations there on February 2. The company plans to introduce two 50L bioreactors in the first half of this year to establish a mass-production system. It aims to obtain full GMP certification by 2028 and expects that, at full capacity, it will be able to supply an additional 10% of Korea’s annual platelet demand.

Exterior view of the production facility in Anyang, Gyeonggi, acquired by Dyusel. Photo by Dyusel

The company is currently in the process of raising 20 billion won in Series C funding, bringing its cumulative investment to 40 billion won. It is targeting an initial public offering (IPO) in 2028 and is primarily considering a technology-special listing. Lee said, “What matters more than market share is how much we can produce,” adding that the goal is “to create a market that does not exist.” His blueprint is for Korean patients to actually use Dyusel’s artificial platelets five years from now, and for Korean-made artificial platelets to be supplied worldwide ten years from now.

This content was produced with the assistance of AI translation services.