Daewoong Pharmaceutical Obtains Cell Processing Facility Approval... Full-Scale Promotion of CDMO Business

Yongin Daewoong Bio Center exterior view.

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 20th that it has obtained approval from the Ministry of Food and Drug Safety for an Advanced Regenerative Medical Cell Processing Facility (cell processing facility).

For the development and handling of advanced biopharmaceuticals and cell and gene therapies, it is required to obtain approval for ▲advanced biopharmaceutical manufacturing ▲human cell management ▲cell processing facilities as stipulated by the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals." Daewoong Pharmaceutical met the first two conditions in January last year and April this year, respectively, and with the recent approval for the cell processing facility, it now holds all the necessary conditions for the CDMO business.

In particular, with this cell processing facility approval, Daewoong Pharmaceutical can supply collected, tested, and processed human cells to regenerative medical institutions, thereby expanding its business scope. Based on this, Daewoong Pharmaceutical plans to accelerate its "All-in-one package" business, which encompasses the CDMO-structured manufacturing and development of cell and gene therapies and advanced biopharmaceuticals, quality testing, regulatory support, storage, delivery, and sales.

Ryu Jae-hak, Head of Bio R&D Division at Daewoong Pharmaceutical, stated, "We will accelerate the CDMO business to advance the development of advanced biopharmaceuticals," adding, "Furthermore, we aim to contribute to improving patients' quality of life."

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