Helixmith Holds CGT Plant Completion Ceremony

[Asia Economy Reporter Jang Hyowon] Helixmith established a ‘CGT Plant’ at its headquarters in Magok, Seoul, dedicated to the specialized production of gene and cell therapies, and held an online completion ceremony on the 13th. The event was conducted online in a non-face-to-face manner in accordance with COVID-19 prevention guidelines.

Helixmith held a plaque ceremony on the 13th to commemorate the completion of the gene and cell therapy specialized factory, 'CGT Plant.' Attendees, including CEO Seungshin Yoo (3rd from the right), President Wonho Park (3rd from the left), and Head of Production Division Kyungdong Bae (2nd from the right), are taking a commemorative photo. Photo by Helixmith

The event was attended by about 30 officials from industry organizations and companies, including Kwon Heechung, President of the Korean Society for Gene and Cell Therapy, Lee Cheolgyun, President of the Korean Society for Biotechnology, Lee Seunggyu, Vice Chairman of the Korea Bio Association, as well as Cytiva, GC Green Cross EM, Merck, Sartorius, and Thermo Fisher.

Helixmith decided to enter the CDMO (Contract Development and Manufacturing Organization) business as domestic and international clinical demand for gene and cell therapies has explosively increased. According to the global market research firm Frost & Sullivan, the gene and cell therapy CDMO market is expected to grow at an average annual rate of 31%, from $1.5246 billion in 2019 to $10.1134 billion by 2026. Helixmith established the CGT Plant with the goal of developing gene and cell therapy processes and analytical methods and producing clinical samples.

Virus-based gene and cell therapies are a recently active research and development field with promising new drugs expected. CAR-T cell therapy is a representative example. However, CDMO companies with specialized facilities and expertise tailored to the domestic market are very limited.

The Helixmith CGT Plant is equipped with an operational and organizational system that meets the GMP (Good Manufacturing Practice) standards for advanced biopharmaceuticals. It is broadly composed of ▲a manufacturing division responsible for producing gene and cell therapies such as viral vectors and CAR-T ▲a quality control division responsible for quality testing of raw materials, intermediates, active pharmaceutical ingredients, finished products, and environmental monitoring tests ▲an engineering division that produces and supplies utilities suitable for manufacturing and quality control testing ▲and a quality assurance division that monitors all these areas and is responsible for product release approval.

Yoo Seungshin, CEO of Helixmith, said, “Through the completion of this CGT Plant, Helixmith has acquired global-level gene and cell therapy production capabilities,” adding, “Based on 25 years of experience and know-how, we will demonstrate differentiated competitiveness in gene and cell therapy development and the CDMO business.” He further stated, “Our subsidiary Cartexel is the first client, and we will strive to attract domestic and international customers, focusing on biotech startups developing new drugs.”