Helixmith Obtains Manufacturing License for Advanced Biopharmaceuticals

[Asia Economy Reporter Hyungsoo Park] Helixmith announced on the 17th that it has obtained a manufacturing license for advanced biopharmaceuticals from the Ministry of Food and Drug Safety.

Last year, Helixmith established the ‘CGT Center (Cell & Gene Therapy Center)’ at its headquarters in Magok, Seoul, to produce GMP-grade cell and gene therapy products. After one year of preparation, it acquired the manufacturing license for advanced biopharmaceuticals.

According to the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (the Advanced Regenerative Medicine Act)," manufacturing advanced biopharmaceuticals requires a special manufacturing license for cell therapy and gene therapy products. To obtain this license, the following requirements must be met: securing manufacturing workspaces and special equipment and instruments necessary for production of advanced biopharmaceuticals; having special spaces, equipment, and facilities for independent testing and inspection to ensure quality control; and securing storage facilities or equipment to hygienically store advanced biopharmaceuticals.

Helixmith’s CGT Center targets biopharmaceutical development companies aiming to develop cell and gene therapy products. It focuses on manufacturing the cell and gene therapy products desired by companies and providing world-class, high-quality clinical samples by thoroughly analyzing the produced pharmaceuticals to verify their quality.

The CGT Center offers comprehensive solutions across all areas, including manufacturing itself, provision of proprietary vectors, process development, and analytical technology development. By simply providing the nucleotide sequence to the CGT Center, a one-stop service is offered that can produce CAR-T products within two years and advance them into clinical trials.

Helixmith plans to soon obtain a human cell management license to complete subsequent processes and firmly establish its CDMO business on a solid track.

Baek Gyeong-dong, Executive Director of Helixmith, said, "This will accelerate the progress of the cell and gene therapy CDMO business," adding, "Based on the technology and know-how accumulated over the past 20 years through gene therapy development, we will play a significant role in strengthening the international competitiveness of domestic advanced biopharmaceutical companies."