Celltrion announced on November 17 that it will acquire 2 million shares of Celltrion BioSolutions for KRW 10 billion (approximately USD 7.4 million), securing 100% ownership of the company. This acquisition marks a strategic step toward establishing a comprehensive Contract Development and Manufacturing Organization (CDMO) business.

According to Celltrion, the decision to pursue a full-fledged CDMO business was made in September in response to growing global demand for biopharmaceuticals and an increasing number of CDMO requests from both domestic and international clients. The company is currently expediting the incorporation process for Celltrion BioSolutions and moving forward with infrastructure development, including production facility construction and operational readiness.

The new entity will offer end-to-end services for drug development, covering the entire pharmaceutical development cycle from drug candidate selection, cell line and process development, clinical trial planning, regulatory filing, and commercial production.

Celltrion BioSolutions aims to leverage Celltrion's past experience in Contract Manufacturing Organization (CMO) services, which dates back to 2002. Although Celltrion shifted its focus to biosimilar development in the late 2000s, the company now intends to re-enter the CMO/CDMO market with a competitive edge.

Celltrion explained that it will capitalize on its extensive track record of global pharmaceutical partnerships and the operational know-how it has accumulated from manufacturing and regulatory activities. By optimizing facility expansion costs and enhancing production efficiency, the company aims to achieve cost competitiveness that will drive production orders.

Regarding production capacity, Celltrion is currently evaluating potential sites for the new production facility. The company plans to build a production facility in South Korea with a total capacity of up to 200,000 liters. Construction on the first plant, with a capacity of 100,000 liters, is expected to begin next year. The company will continue to assess optimal production capacity and site conditions to support ongoing supply needs.

The establishment of production facilities will be supported through a combination of internal and external funding. Initially, Celltrion Group will invest up to KRW 1.5 trillion (approximately USD 1.1 billion) for the construction of core infrastructure and the launch of Contract Development Organization (CDO) services. The company also plans to raise an additional KRW 1.5 trillion from external investors to fund the expansion of specialized research centers and next-generation modality production facilities.

The new facility will be equipped with a range of large- and small-scale bioreactors to support large-scale production. It will also house production lines for next-generation modalities, including Antibody-Drug Conjugates (ADCs), bispecific antibody therapies, cell and gene therapies, and peptide-based drugs.

To enhance its capacity for next-generation modalities and expand its production portfolio, Celltrion plans to establish specialized research centers in strategic locations worldwide, including the United States, Europe, and India. These centers will focus on integrating cutting-edge technologies into the CDMO framework and providing comprehensive development and manufacturing solutions. The company anticipates that commercial production will commence in 2028, at which point it expects to generate significant revenue.

A Celltrion Group official stated, "Leveraging the know-how accumulated over the past 20 years, we have launched a CDMO subsidiary that can provide tailored services at every stage of the drug development lifecycle. BioSolutions will prioritize cost competitiveness and customer-centric policies to deliver true end-to-end services for our clients."

With the launch of Celltrion BioSolutions, the company aims to strengthen its foothold in the global CDMO market, establish cost-efficient production capabilities, and position itself as a major player in the next-generation biopharmaceutical manufacturing industry.