ST Pharm "Oligo Manufacturing Facility Passes US FDA Routine Inspection"

ST Pharm recently announced on the 25th that it has passed the regular current Good Manufacturing Practice (cGMP) inspection for its oligo manufacturing facility at the Banwol Campus by the U.S. Food and Drug Administration (FDA) and received the Establishment Inspection Report (EIR).

ST Pharm oligo manufacturing facility. [Photo by ST Pharm]

With this FDA inspection clearance, ST Pharm explained that it has been recognized as a manufacturing facility capable of stably producing and supplying high-quality oligos that meet global pharmaceutical manufacturing and quality control standards.

ST Pharm's Banwol Campus has been increasing its oligo production capacity through continuous investment. After constructing the first oligo building in 2018, it expanded the 3rd and 4th floors in 2020, and recently began construction of the second oligo building. Once the expansion of the second oligo building is completed, the oligo production capacity will increase from the current annual 6.4 mol to a maximum of 14 mol per year by 2026. This is the world's largest scale in terms of oligo production capacity.

ST Pharm is preparing for multiple FDA Pre-Approval Inspection (PAI) audits next year. This is because some new drugs for oligonucleotide therapeutics, for which ST Pharm supplies raw materials, are approaching commercialization for indications such as hematologic cancers and cardiovascular diseases. The company expects that passing this manufacturing facility inspection will serve as a positive indicator.

An ST Pharm representative stated, "By passing the cGMP regular inspection at the Banwol Campus, ST Pharm has secured world-class competitiveness in oligo manufacturing. This will enable us to supply raw materials on a large scale for commercialization in advanced markets such as the U.S., which is expected to expand sales." He added, "After undergoing FDA PAI inspections next year, ST Pharm’s CDMO (Contract Development and Manufacturing Organization) business, including the expansion of oligo project orders, is expected to gain further momentum."

Meanwhile, last year ST Pharm became the first in Asia to pass the FDA PAI inspection for oligo production facilities. The inspection resulted in a No Action Indicated (NAI) rating, indicating no issues were found. Through this, ST Pharm became the first CDMO company in Asia to receive FDA certification not only for low-molecular-weight chemically synthesized active pharmaceutical ingredients but also for oligonucleotide therapeutic active pharmaceutical ingredients.

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