Tony Hagen is senior managing editor for The Center for Biosimilars®.
The Songdo district of Incheon, Republic of Korea, is rapidly becoming a major biopharmaceuticals production center.
For one company deeply involved in the production of biosimilars, expansion efforts are moving ahead where the company feels it is safest, given how well countries targeted for factory construction are managing coronavirus disease 2019 (COVID-19).
A little under 2 weeks ago, Celltrion announced that it would start building a $453.3 million biopharmaceutical factory in the Songdo district of Incheon, Republic of Korea, just southwest of Seoul, the capital city. Construction began on November 18, 2020, immediately following the announcement, and completion of the plant and a global research and development center are anticipated by May 2023. This construction is moving forward despite the pandemic.
Republic of Korea exceeded 500 new cases of COVID-19 on November 29, according to the Korea Disease Control and Prevention Agency. Since the beginning of November, the country has seen a resurgence of cases that has authorities now banning New Year celebrations and restricting other public gatherings.
Meanwhile, Celltrion continues to suspend construction activities related to its planned Wuhan factory site, where it announced early in 2020 the start of construction for a $514 million biologics plant, which would manufacture medicines for the Chinese market and perform contract manufacturing for other companies. That project didn’t get very far.
In January 2020, Celltrion withdrew its employees from Wuhan because of the pandemic and indicated it would monitor conditions before resuming activities. A spokesperson for Celltrion said this week that the Wuhan plans remain a reality, although the pandemic continues to be the reason for the construction suspension. “The Wuhan project is currently on hold because of the worldwide COVID-19 pandemic,” said Taegyun Kim.
At the time that Celltrion evacuated its employees from Wuhan, the city of 11 million was the global epicenter of the COVID-19 outbreak. The current, official infection rate and total number of cases in China are disputed owing to suspicions of significant underreporting. According to a tally of new cases for November 29, based on various official sources, the count was 18, far lower than in Republic of Korea.
However, having a centralized system of epidemic response, contact tracing, a high respect for medical science, and s recent experience battling a serious contagion with high mortality (SARS-CoV), China was in an excellent position to combat COVID-19, according to a review article in The Lancet. These factors support the notion that China has adopted a much more sophisticated and successful approach to managing COVID-19 than many other countries. Wuhan, in Hubei province, was originally placed under strict lockdown that lasted for 76 days. Public transport was halted, and checkpoints were established at transit centers. Family outdoor activities also were curtailed, and only 1 member of a family was allowed out to obtain needed supplies. Testing of 9 million citizens was completed within weeks, the article said.
Republic of Korea also has been held up as an example of successful COVID-19 response, although the resurgence there has prompted a tightening of restrictions.
Managing the COVID-19 Risk
Discretion may be the better part of valor for Celltrion, which, being based in Incheon, is much more familiar with conditions there than in China, although it ultimately wants to expand manufacturing operations in both markets. Celltrion has 2 existing manufacturing plants in Incheon, with capacity of 190,000 L of biomedicine production. The new plant under construction will add 60,000 L of capacity, with 8 bioreactors, for a total potential volume of 250,000 L, according to Kim. “The major purpose of the third plant will be to reinforce our multiproduct, small-size manufacturing capacity,” he said.
Three hours by plane to the southwest, the planned Wuhan manufacturing center would produce biopharmaceuticals for the Chinese domestic market and include a large-scale contract manufacturing facility for work with Celltrion’s clients, Kim said.
Both plants were envisioned in 2019 when Celltrion issued its “Vision 2030” blueprint for company expansion in the global biopharmaceuticals sector. The company anticipated spending $33.6 billion over the coming decade, during which it anticipated bringing at least 1 new biosimilar to market each year and challenging Pfizer for the lead position in the global pharmaceuticals industry. At the time, Celltrion had 3 biosimilars approved and marketed and intended to bring that number to 18 by 2030, which would require expansion of biomedicine production capacity to 1 million L yearly. The Wuhan factory would have capacity for 120,000 L. Combined with the anticipated 250,000-L total in Republic of Korea, these factory projects would bring the company 37% of the way to the 1-million L goal.
Republic of Korea is becoming a center of biologics manufacturing. Government information reported by the Korea Biomedical Review indicated that 68.2%, or $874.5 million of the country’s $1.28 billion in biopharmaceutical exports in 2019, were biosimilars. The country’s biopharmaceutical market reached $2.17 billion last year, up 16.6% from the previous year, with annual growth clocking in at 10.2%. Not just Celltrion, but others also are racing to get ahead in the biopharmaceuticals market.
This past summer, Samsung Biologics, also a significant player in the biosimilar market, announced plans to build a fourth factory in Incheon, also in the Songdo district. This factory alone would have a capacity of 256,000 L, which Samsung said would be a global record for single-plant bioproduction capacity. The plant is intended to satisfy growing international demand for contract manufacturing. Although the factory announcement was made in August 2020, construction was scheduled to begin in September, with production expected to be partially compete by the end of 2022.
The Celltrion spokesman said the Samsung Biologics project has not caused Celltrion to accelerate its plans. “Celltrion Group announced its future growth plan Vision 2030 in May 2019. The construction of the third plant and the global R&D center is part of this plan,” he said.