[Company Visit] Pharmicell "Tripling Cell Therapy Production Capacity with Expansion of Plant 2"

Completion Ceremony of Plant 2 Held... "Expectations for Pipeline Strengthening"
Continued Growth with Establishment of Stem Cell Specialized Hospital in 2025

"After the operation of the Seongnam 2nd Factory, the production capacity of stem cell therapeutics will be tripled, and sales are expected to increase. The 2nd Factory is a GMP (Good Manufacturing Practice) facility designed as a next-generation smart factory, which will further strengthen the pipeline of stem cell therapeutics currently in clinical trials."

Kim Hyun-soo, Chairman of Pharmicell, delivering a commemorative speech at the completion ceremony of GMP Seongnam Plant No. 2. Photo by Yoo Hyun-seok

Kim Hyun-soo, Chairman of Pharmicell, said this at the 'Cell Therapy GMP Seongnam 2nd Factory Completion Ceremony' held recently at Pharmicell's office in Jungwon-gu, Seongnam-si, Gyeonggi-do.

Pharmicell is a stem cell specialized company established in 2002. In 2011, it launched 'Haticelgram,' the world's first stem cell therapeutic. Its main business sectors are biochemical and biomedical.

The newly expanded GMP Seongnam 2nd Factory is located within the same Sikoksta Tower in Seongnam-si, Gyeonggi-do, as the existing GMP 1st Factory.

The existing 1st Factory is on the 9th floor, and the newly expanded 2nd Factory is on the 5th floor. About 10 years ago, a space of approximately 1,116.4㎡ (about 338 pyeong) was secured, and 5 billion KRW was invested to expand it into an advanced pharmaceutical manufacturing and quality control facility. The 2nd Factory consists of manufacturing management rooms such as aseptic workrooms and cell storage rooms, quality control rooms capable of microbial testing and cell culture, material storage, and auxiliary facilities.

Jung Gil-soo, Executive Director of Pharmicell, explained, "The current facilities have aged, increasing maintenance tasks, and with the revision and strengthening of GMP-related regulations, there was a need for new facilities. The Seongnam 2nd Factory will proceed with full-scale operations after receiving GMP compliance certification from the Ministry of Food and Drug Safety."

Kim Hyun-soo, Chairman of Pharmicell, and guests listening to an explanation about the GMP Seongnam Plant No. 2. Photo by Yoo Hyun-seok

Pharmicell expects the expansion of the 2nd Factory to boost its Contract Development and Manufacturing Organization (CDMO) business. CDMO combines Contract Manufacturing Organization (CMO) and Contract Development Organization (CDO) businesses. It goes beyond simply producing clinical trial and commercial drugs on consignment; it refers to a collaborative structure with partners that supports the entire new drug development process from cell line development to clinical trials and market approval.

Chairman Kim Hyun-soo emphasized, "With this factory expansion, the diversification of product development and the expansion of quality control laboratories will further grow the contract business. As a result, the strengthened CDMO business will become a new growth engine for the biomedical division."

After the completion ceremony, we entered the 2nd Factory. The most noticeable feature in the 2nd Factory was the large monitor installed at the entrance. It allowed real-time monitoring of conditions such as temperature, humidity, and particles inside the factory. Yang Sun-ja, Head of Pharmicell GMP Center, explained, "The 2nd Factory is designed to enable the development and production of cell therapies using various cells and raw materials. Each workspace has its own separate workflow, which is a distinctive feature."

People touring the interior of Pharmicell GMP Seongnam Plant No. 2. Photo by Yoo Hyun-seok

When entering manufacturing management rooms such as aseptic workrooms and cell storage rooms where products are produced, personnel must follow gowning procedures including wearing cleanroom suits and caps. A company official explained, "This area is classified as B level, and each level has different cleanliness management standards. We pay close attention to cleanliness by discarding caps and gloves after use and sterilizing the worn cleanroom suits."

The exit route after touring the internal facilities was different from the entrance path. Although the entrance was the same, the paths for entering and exiting were different. A company official said, "After work, waste is generated. This is to minimize contamination from such materials."

The 2nd Factory is currently undergoing validation work to obtain GMP certification from the Ministry of Food and Drug Safety. Once completed, it will receive GMP compliance certification and begin production. Full-scale operation is scheduled to start from the first quarter of next year.

Pharmicell plans to continue growing without being satisfied with the current status. Chairman Kim Hyun-soo emphasized, "Pharmicell has grown by conducting biomedical and biochemical businesses. By 2025, we will also establish a specialized hospital for stem cell therapeutics and create a new history as a global market-leading company."