ST Pharm, Asia's First Oligo Manufacturing Facility to Obtain US FDA cGMP Certification

[Asia Economy Reporter Lee Gwan-joo] ST Pharm announced on the 1st that it has obtained cGMP (current Good Manufacturing Practice) certification for oligo manufacturing facilities from the U.S. Food and Drug Administration (FDA), becoming the first in Asia to do so.

The FDA inspection team visited ST Pharm's Banwol Campus oligo building from May 16 to 20 to conduct a pre-approval inspection (PAI) of the manufacturing site before new drug approval.

The PAI inspection is an essential procedure for new drug approval and supply of active pharmaceutical ingredients (APIs). ST Pharm received a flawless (NAI, No Action Indicated) rating, with no issues found and no need for corrective submissions.

Until now, ST Pharm was only able to export clinical-grade oligonucleotide therapeutic APIs to the U.S. market. With this FDA cGMP approval, ST Pharm can now export large-scale commercial quantities to the U.S. market.

An ST Pharm official stated, “Passing the FDA PAI inspection for oligo production facilities as the first in Asia and receiving a flawless rating with no issues found once again proves ST Pharm’s cGMP capabilities. With this approval, we expect an expansion in oligo project orders as we can export large-scale oligo APIs to the world’s largest market, the U.S., and anticipate that ST Pharm’s business, including mRNA CDMO, will gain further momentum.”