[Exclusive] Celltrion Localizes Clinical Analysis Functions Previously Outsourced Overseas

Reduce Costs by 4 to 5 Billion Won per Project

Construction site view of Celltrion Global Biotechnology Research Center. / Incheon = Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Seo So-jung] Celltrion will independently perform clinical analysis functions for biosimilars (biopharmaceutical generics) and antibody therapeutics, which had previously relied on overseas Contract Research Organization (CRO) companies. The company plans to develop this capability further to provide clinical analysis services to other companies in the long term.

According to Celltrion on the 18th, the company has decided to directly carry out clinical analysis functions such as blood analysis, which had been entirely entrusted to overseas CRO companies. Until now, while developing biosimilars and antibody therapeutics, Celltrion spent tens of billions of won per project on clinical analysis by outsourcing to overseas CRO firms, but it will now internalize this process.

Through this, the goal is to drastically reduce the development period for products such as biosimilars and antibody therapeutics and also cut costs.

A team performing clinical analysis functions will be housed on one floor of the Global Biotechnology Research Center, scheduled to be completed in Songdo, Incheon, in July next year.

Celltrion’s COVID-19 antibody therapeutic, ‘Rekkirona,’ is currently accelerating efforts to obtain formal product approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In this process, Celltrion has been outsourcing clinical analysis to overseas companies, paying 4 to 5 billion won per project.

Although there are several domestic CRO companies, to conduct large-scale global clinical trials and obtain approval from global regulatory agencies, reliance on overseas CRO companies is inevitable. Leading overseas CRO companies such as Covance, PPD, and Syneos have accumulated personnel and expertise in global clinical trials, which helps reduce research and development (R&D) risks and enables effective drug development.

Kwon Ki-sung, Head of Celltrion’s R&D Division, stated, "Until now, Celltrion has fully entrusted overseas CROs, but by conducting clinical analysis internally, we can reduce costs and shorten development time." He added, "We plan to internalize clinical analysis and provide services as a clinical analysis institution in the long term."

As a first step into CRO, Celltrion will initially perform clinical analysis for antibody therapeutics independently. Once expertise is accumulated, the company plans to establish a system and launch full-scale services. This aims to reduce dependence on overseas CROs and prevent foreign currency outflow.

Kwon said, "We have secured an independent space in the Global Biotechnology Research Center that meets international standards." He added, "The initial focus will be on Celltrion products, but as personnel and expertise accumulate, we plan to expand into the chemical field in the long term and provide services to other companies."