ST PHARM, a subsidiary of the Dong-A Socio Group, announced on Oct. 25 that its Oligo manufacturing facility, Banwol Campus, has successfully passed its regular Current Good Manufacturing Practices (cGMP) inspection conducted by the U.S. Food and Drug Administration (FDA). The company has also received an Establishment Inspection Report (EIR).
With this FDA inspection approval, ST PHARM is now recognized as a manufacturing facility that can consistently produce and supply high-quality oligonucleotides, or oligos, meeting global pharmaceutical manufacturing and quality management standards. This certifies their competitive edge at a global level.
The Banwol Campus of ST PHARM, which has met the cGMP standards, has been continually enhancing its oligo production capacity through consistent investment. Following the construction of the first oligo building in 2018, the company expanded by adding third and fourth floors in 2020. Recently, they have commenced the construction of a second oligo-focused building. Once the expansion of the second oligo building is completed, the company’s oligo production capacity is projected to increase from the current annual 6.4 mol to a maximum of 14 mol by 2026, positioning the company as the world’s top enterprise in terms of oligo production capacity.
Importantly, with several new drugs aiming for commercialization next year – particularly for blood cancer and cardiovascular diseases, for which ST PHARM supplies raw materials – a number of FDA pre-approval inspection reviews are scheduled. This recent manufacturing facility inspection approval is seen as a positive indicator.