[Onejoon Co., Ltd. (Gangwon) = E-Daily Reporter NA EUN-KYUNG ] Cellac Bio has secured six contract manufacturing organization (CMO) clients for fillers ahead of the launch of its new plant in Wonju. The company is also in discussions for four additional contract development and manufacturing organization (CDMO) projects. The plan is to first produce external contract orders to maximize plant utilization until it receives product approval for its own medical devices, with the goal of generating up to 20 billion won in revenue from its CMO and CDMO businesses next year.

Lee Jae-hyuk, co-CEO of Cellac Bio, spoke with Edaily following the opening ceremony for the Wonju plant held on the 29th of last month in Jiseong-myeon, Wonju, Gangwon Province. “We have currently signed supply contracts with six CMO companies and are in discussions for four additional CDMO projects,” he said, adding, “Our revenue target for CMO and CDMO next year is between 10 billion and 20 billion won.”

Onejoon Co., Ltd. Wonju Plant

Built with 70 Billion Won Investment… Targeting KGMP Certification by April Next Year

Cellac Bio held the opening ceremony for its new plant in the Wonju Enterprise City today. Construction on the Wonju plant began in February of last year and was completed this past April, with approximately 70 billion won invested in the facility, including construction and production equipment. Built on a site of approximately 9,917.4 square meters (3,000 pyeong) as a three-story structure, the plant is capable of producing more than 16 million dermal fillers annually.

However, the completion of the plant does not immediately signify the start of commercial production. Cellac Bio plans to begin producing products for clinical trials after receiving certification of compliance with the Korean Good Manufacturing Practice (KGMP) standards for medical devices in April of next year. The company has set a target operating rate of at least 10% for next year.

The roles of the existing Uiwang and Wonju plants are also distinct. The Uiwang Research and Development (R&D) hub is responsible for raw material and formulation research, production process development, pilot production, and the manufacture of samples for preclinical trials. It is a facility designed to verify the commercial viability of various candidate compounds by producing them in small quantities. The Wonju plant will serve as a commercialization hub, scaling up the processes established in Uiwang for mass production and performing aseptic filling as well as CMO and CDMO services.

The initial production lines at the Wonju plant are expected to be filled first with CMO and CDMO orders from external clients rather than the company’s own products. Cellac Bio aims to begin domestic clinical trials for its proprietary medical devices in 2027 and obtain product approval by 2029. The company’s strategy is to secure plant utilization rates and revenue through contract manufacturing while awaiting approval for its own products.

Co-CEO Lee explained, “While the Uiwang plant is where we develop products and manufacturing processes, the Wonju plant will be responsible for mass-producing them and supplying them to the global market,” adding, “It was designed to meet high standards of manufacturing and quality control with the goal of obtaining approval from the U.S. Food and Drug Administration (FDA).”
Diversification

from Raw Materials to Formulations… “Contract Manufacturing Under One Roof”

Celac Bio’s key differentiator is its ability to produce various raw materials and formulations

at a single facility

. The Onejoon Co., Ltd. plant is designed to produce calcium hydroxylapatite (CaHA), poly-L-lactic acid (PLLA), collagen, hyaluronic acid (HA), and DOPA-based products in various forms, including vials, pre-filled syringes (PFS), and freeze-dried products.

The manufacturing process and filling method for fillers vary depending on the raw material. HA fillers require a high-viscosity gel to be filled into PFS at a specific volume. In contrast, particulate collagen stimulants such as PLLA are often freeze-dried while controlling particle size and dispersion uniformity, and then produced in vial form. Since these products are dissolved in water before use, the ability to manage freeze-drying and aseptic processes is critical to quality.

For CaHA and collagen-based products as well, the conditions for mixing, dispersion, and sterilization vary depending on the characteristics of the raw materials. Cellac Bio’s competitive advantage lies in the fact that manufacturers do not need to seek separate production facilities suited to each raw material and formulation; instead, they can entrust everything—from product development to aseptic filling and mass production—to a single plant. Unlike facilities optimized for individual raw materials or single formulations, Cellac Bio explains that its plant can simultaneously handle contract manufacturing for multiple types of fillers, making it easier to diversify both client bases and product lines.

The Wonju plant was designed in compliance with the European Medical Device Regulation (CE MDR) and FDA requirements and is equipped with pharmaceutical-grade aseptic filling facilities. Building on this foundation, Celac Bio plans to expand its business into the CDMO sector, supporting not only production for domestic clients but also process development and the preparation of quality documentation required for overseas regulatory approvals.

Co-CEO Lee stated, “Since our proprietary products require time for clinical trials and approval, we will secure initial operating rates through contract manufacturing, which generates revenue regardless of regulatory approval schedules.”

The company has set its total revenue target for this year at 10 billion won. The projected revenue breakdown is 20% from proprietary products, 30% from CMO services, and 50% from business-to-consumer (B2C) cosmetics. Under this structure, the cosmetics business will serve as the revenue base through this year, while CMO and CDMO services will drive growth starting next year. Cellac Bio aims to reach the break-even point by 2028 and list on KOSDAQ by 2030.

Cellac Bio is a medical aesthetics company founded in May 2024 by Co-CEO Moon Kyung-yeop, a co-founder of Hugel, Inc.(145020), and CEO Lee Jae-hyuk, who previously oversaw sales and marketing at Hugel, Inc. The company is developing PLLA, CaHA, and collagen fillers, and is expanding its business into skin-whitening functional cosmetics, human all-dermal matrix (hADM) products, and CMO/CDMO services. Last year’s revenue reached 818.85 million won, a 309.4% increase from the previous year; however, the company posted an operating loss of 9.43541 billion won due to ongoing investments in R&D and workforce expansion. The company aims to achieve 10 billion won in revenue this year, primarily through its B2C business—including skin-whitening cosmetics—and to reach the break-even point by 2028 by fully launching CMO and CDMO operations at its Wonju plant starting next year.

Meanwhile, Cellac Bio established a joint venture, TFE Co., Ltd., after receiving 13 billion won in common stock investment last March from The Founders, the operator of the cosmetics brand Anua. The Founders holds a 60% stake and Cellac Bio holds 40%, with an initial capital contribution of 2 billion won. Co-CEO Lee said, “The two companies plan to jointly develop next-generation skin boosters by combining Cellac Bio’s manufacturing technology with The Founders’ online marketing capabilities.”