Helixmith Holds Workshop on Commercialization of CAR-T Technology

[Asia Economy Reporter Jang Hyowon] Helixmith announced on the 22nd that it held a CAR-T technology commercialization workshop at its headquarters in Magok, Seoul on the 21st.

Thu Doan, Head of the Regulatory Affairs Division, shared her experience in CAR-T development from the perspective of the U.S. FDA regulations, and CEO Kim Sunyoung introduced the CGT Plant for gene and cell therapy product manufacturing facilities. Many bio-industry stakeholders attended the event, including representatives from Green Cross, Cellgen, GI Cell, Cartexel, Kolon Life Science, ToolGen, Ticaros, and LG Chem.

Dr. Thu Doan oversees the Regulatory Affairs (RA) division at Helixmith in the U.S. With 15 years of experience in regulatory affairs, she previously worked at Kite Pharma, which launched the CAR-T therapy Yescarta. On this day, Dr. Doan explained the CAR-T products Kymriah and Yescarta, which are currently approved solid tumor-targeting CAR-T therapies, based on her successful experience in obtaining CAR-T product approvals.

As an RA expert, she also introduced the U.S. FDA regulatory policies and directions. She explained key FDA guidelines such as the newly established Long-Term Follow-Up (LTFU) from January last year, Risk Evaluation and Mitigation Strategy (REMS), and recommendations for replication competent retrovirus (RCR) vector-based gene therapies.

Meanwhile, Helixmith established the CGT Plant (Cell & Gene Therapy Plant) at its Magok headquarters in Seoul last September, aiming to develop gene and cell therapy product processes and analytical methods, as well as produce clinical samples. The CGT Plant has an operational and organizational system that complies with advanced biopharmaceutical GMP (Good Manufacturing Practice) standards.

The CGT Plant is characterized by its capability to provide comprehensive solutions across manufacturing, processing, and analysis for gene and cell therapy product production, and it also houses a negative pressure manufacturing room for virus vector production. During the workshop, Helixmith allowed developers preparing for gene and cell therapy product development and commercialization to tour the production facilities.

Helixmith CEO Kim Sunyoung stated, “We will demonstrate differentiated competitiveness not only by supplying services and solutions as a partner to domestic and international CAR-T developers and gene and cell therapy developers but also by advancing to joint development. We will actively strive to play a valuable role in the development of the gene and cell therapy industry.”

This content was produced with the assistance of AI translation services.