Based on the Bulk Good-Manufacturing Practice (BGMP) of Korea, we developed standard operating procedures (SOP) for the production of medical clays. SOP documents include general provisions and regulations that are necessary for quality assurance (QA) and quality control (QC) of medical clays. Production of 0.1 ton of medical clay of reagent grade, satisfying standards described in Korea Pharmacopoeia, was succeeded using BGMP facility. We also had a ceremony for technology transfer to a Bio-company of five incrementally-modified drugs (IMDs), materials derived from medical clays. The company was the first ‘INNOPOLIS Research Institute Spin-off Company’ that was established in Pohang-si.
On September 2019, a 10 ton/yr scale testbed with outdoor silos was built in the branch. Research funding was granted for five years by the Ministry of Trade, Industry and Energy (MOTIE) and related local governments (Gyeongsangbuk-do and Pohang-si). Conceptual and detailed design of clean room facility for mass production of medical clays will be finished by 2020. The facility, with the necessary infrastructure, equipment, and instrumentation, will be completed in 2021.
Contact: Jaehwan Kim (jaehwankim@kigam.re.kr)
