[K Manufacturing, On Site] Research, Clinical, and Production 'One-Stop'... K-Bio Future Celltrion

Building a Comprehensive R&D Center with 500 Billion Investment
Accelerating New Drug Development Beyond Generics
Developing Digital Healthcare Platform
Conducting Clinical Analysis In-House Without Overseas Outsourcing
Core Base for Leap to Global Top 10 by 2030

A global biotechnology research center under construction on a site near Celltrion Plant 2, with a land area of 10,033㎡ (approximately 3,000 pyeong), consisting of one basement floor and six above-ground floors. / Incheon - Photo by Kim Hyunmin kimhyun81@

Celltrion employees are performing final product operations on the first floor filling room (fill&finish) of the Incheon Songdo Plant 2 on the 16th. / Incheon = Photo by Kim Hyun-min kimhyun81@

[Incheon (Songdo) = Asia Economy reporters Seo So-jeong and Lee Chun-hee] "This is where the final formulation process of the COVID-19 antibody treatment ‘Rekkirona’ takes place."

On the 16th, at Celltrion’s Plant 2 in Songdo, Yeonsu-gu, Incheon, the final formulation process of the anticancer biosimilar (biopharmaceutical generic) ‘Herzuma’ was being busily carried out. The same location also handles the final formulation of Rekkirona. Staff clad in cleanroom suits moved their hands busily for finishing tasks such as labeling, and the completed products were carefully placed into boxes. A tense atmosphere was palpable over the shoulder.

Celltrion’s biosimilar production goes through the stages of cell line → culturing → separation and purification → final formulation. Throughout this process, all conditions including temperature, humidity, acidity, and pressure must be strictly observed to ensure the production of safe pharmaceuticals. Since external exposure is absolutely prohibited, all products are transported thoroughly enclosed within piping systems.

The filling and packaging of products are conducted in a strictly aseptic facility. As the first in Asia to obtain the U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) certification for animal cell culture facilities, every step is meticulously managed.

Rekkirona Phase 3 Clinical Trial Confirms Efficacy and Safety… EMA and U.S. FDA Approval Signals Green Light

The production of Rekkirona’s active pharmaceutical ingredient (DS) is carried out at Plant 1, while the final drug product (DP) formulation is done at Plant 2. Following the recently released global Phase 3 top-line results demonstrating efficacy and safety, positive signals have emerged regarding approvals from the FDA and the European Medicines Agency (EMA).

In the Phase 3 trial involving 1,315 participants, the treatment group showed a 72% reduction in the proportion of high-risk patients requiring hospitalization or who died compared to the placebo group, and a 70% reduction across all patients. The time to clinical symptom improvement was also significantly shortened by 4.7 days in the high-risk group and 4.9 days overall, based on a 48-hour benchmark.

Celltrion plans to submit these Phase 3 top-line results to global regulatory agencies including the FDA and EMA to seek formal approval for Rekkirona. Kwon Ki-sung, Executive Vice President of Research and Development, stated, "EMA is currently conducting a rolling review, and we plan to submit the Phase 3 top-line data within June. We believe this data will pose no significant obstacles to approval."

Celltrion’s Heart: ‘Global Biotechnology Research Center’… Accommodates 2,000 Researchers

The construction site of Celltrion Global Biotechnology Research Center. / Incheon - Photo by Hyunmin Kim kimhyun81@

Right next to Celltrion’s Plant 2, construction was in full swing despite the hot weather. Celltrion is investing a total of 500 billion KRW to build the Global Biotechnology Research Center on a site of 10,033 square meters (approximately 3,000 pyeong) near Plant 2, consisting of one basement floor and six above-ground floors. Completion is scheduled for July next year.

Executive Vice President Kwon introduced the research center as "the heart of Celltrion going forward" and described it as "a core base for leaping into the global top 10 pharmaceutical companies by 2030." Currently, Celltrion’s research and development (R&D) personnel number around 600, accounting for about 30% of all employees, making it the largest workforce among domestic biopharmaceutical companies. Once the research center is completed next year, it will be able to accommodate up to 2,000 researchers.

Kwon added, "The research center will efficiently integrate all R&D functions including research, regulatory preparation, and clinical trials within a single building. It will become a specialized comprehensive R&D center to support growth as a global company."

The ‘three musketeers’ of biosimilars?Remsima, Herzuma, and Truxima?have been the key contributors to Celltrion’s success to date. However, to leap into the global top 10, Celltrion must move beyond biosimilars to develop new drugs and embrace digital healthcare, which will lead future transformations.

Kwon emphasized, "Five pipelines have entered Phase 3 clinical trials as follow-up biosimilars targeting autoimmune and ophthalmic diseases, and these will proceed without setbacks. We also plan to develop new antibody targets for cancer and immune diseases, as well as new antibody-drug conjugates (ADCs)." He added that in the cancer treatment area using bispecific antibodies, Celltrion will establish platforms and develop pipelines through future collaborations.

In particular, the Global Biotechnology Research Center will fully undertake clinical analysis functions. Clinical analysis functions such as blood analysis, which had been entirely outsourced to foreign companies during antibody therapeutic development, will be internalized within the research center to reduce costs and dramatically shorten product development timelines.

Digital healthcare will also accelerate. Kwon stated, "We will develop a digital healthcare platform for disease management and treatment, solidifying our position as a total healthcare research institute that offers solutions across the entire spectrum of prevention and treatment management."