Helixmith Obtains Manufacturing License for Advanced Biopharmaceuticals

[Asia Economy Reporter Lee Chun-hee] Helixmith announced on the 17th that it has received a manufacturing license for advanced biopharmaceuticals from the Ministry of Food and Drug Safety. This achievement comes just over a year after establishing the CGT Center at its headquarters in Magok, Seoul last year for GMP production of cell and gene therapies (CGT).

To manufacture advanced biopharmaceuticals, a special manufacturing license for CGT and related products must be obtained under the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (the Advanced Regenerative Medicine Act)." To obtain this license, companies must meet stringent requirements including securing a workspace capable of manufacturing advanced biopharmaceuticals with specialized equipment and instruments, installing special spaces and necessary equipment for independent quality control testing and inspection, and securing hygienic storage facilities or equipment for advanced biopharmaceuticals, among other facility, space, personnel, and equipment criteria.

The Helixmith CGT Center targets biopharmaceutical development companies aiming to develop CGT. It was established with a focus on rapidly manufacturing the CGT desired by companies and providing high-quality clinical samples by verifying the quality of produced pharmaceuticals. The most notable feature of the CGT Center is its ability to provide comprehensive solutions across all areas, including manufacturing, provision of proprietary vectors, process development, and analytical technology development. The center also offers a one-stop service that allows companies to enter clinical trials within two years by providing a CAR-T product after submitting the nucleotide sequence to the CGT Center.

In addition, Helixmith plans to finalize subsequent processes by obtaining a license for human cell management and firmly establish its contract development and manufacturing organization (CDMO) business.

Baek Kyung-dong, Executive Director in charge of Process Development and Production Headquarters at Helixmith, said, "Obtaining this license has given significant momentum to the CGT CDMO business. We will be able to meet the diverse needs of CGT developers and play a major role in strengthening the international competitiveness of domestic advanced biopharmaceutical companies."

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