Chimeric Antigen Receptor (CAR)-T cell therapy specialist Curecell announced on the 21st that it has obtained a manufacturing license for advanced biopharmaceuticals from the Ministry of Food and Drug Safety.
The approved Curecell's Good Manufacturing Practice (GMP) commercial CAR-T manufacturing facility is established on a 16,636㎡ scale at the new building in the Daejeon International Science Business Belt (Dunggok District). Curecell applied for the advanced biopharmaceutical manufacturing license last month, and after submitting supplementary materials and undergoing a review period, received the manufacturing license certificate from the Daejeon Regional Ministry of Food and Drug Safety on the 20th.
Currently, to develop and handle advanced biopharmaceuticals and cell and gene therapies (CGT), it is mandatory to obtain licenses for cell processing facilities, advanced biopharmaceutical manufacturing, and human cell management as stipulated by the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (the Advanced Regenerative Medicine Act)." To acquire these licenses, facilities must meet requirements including manufacturing sites, equipment, and instruments where the manufacturing process takes place; laboratories and necessary equipment and instruments for quality control of raw materials and advanced biopharmaceuticals; safe and hygienic storage locations and facilities; security access devices; and record storage rooms equipped with devices for work records and document preservation, among other equipment and personnel requirements.
Kim Geonsu, CEO of Curecell, stated, “With the advanced biopharmaceutical manufacturing license granted to Curecell’s Daejeon GMP factory, we are rapidly preparing to implement the plan for domestic production following the Ministry of Food and Drug Safety approval of Curecell’s CAR-T therapy 'Anbalsel' in the second half of next year.” He added, “We will successfully achieve Curecell’s goal of domestic localization of CAR-T therapy production starting in 2025.”
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