· MEDIPOST offers a production capacity of 20,000 vials of CARTISTEM® drug product and plans to complete GMP certification by 2023
· The company completes preparation for the production of drugs for clinical trials of SMUP-IA-01, the next-generation knee osteoarthritis drug, and conversion to commercial production
MEDIPOST announced on the 17th that the company has completed expansion of the production facilities for its knee osteoarthritis stem cell products, CARTISTEM® and SMUP-IA-01, and will start to prepare for GMP (Good Manufacturing Practice) certification.
The GMP facilities have been expanded in strict compliance with the Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (“Advanced Regenerative-Bio Act”) as well as the latest GMP guidelines. MEDIPOST now possesses GMP facilities with a total area of 4,645m2, which include the existing first and second work site and storage site. The facilities are capable of producing 20,000 vials of CARTISTEM® drug product and can also fully support the production of the next-generation stem cell SMUP-Cell pipeline products such as SMUP-IA-01 (an injectable knee osteoarthritis treatment) and SMUP-IV-01 (intravenous injection for acute respiratory distress syndrome).
To increase production efficiency, the company purchased a site adjacent to the existing GMP facilities in Guro Digital Complex early last year and completed facility expansion and equipment installation in just 16 months from breaking ground last September, at a cost of about 15 billion won.
With a total floor area of about 1300m2, the new facility includes an SMUP-IA-01 (an injectable knee osteoarthritis treatment) production line that can cultivate large amounts of selected high-efficiency stem cells and installations for cold storage of drug products after the filling and finishing processes. MEDIPOST can now produce up to 20,000 vials per year and has also completed preparations for commercial production as well as for the next phase of Korean and international clinical trials scheduled in the second half of this year.
In addition, the SMUP-Cell clinical trial drug production line in the existing Guro Digital Complex GMP facility has been converted to CARTISTEM® production line. With the current capacity for Drug Substance (DS) and Drug Product (DP) production, the line can produce about 10,000 to 20,000 vials, allowing the company to respond not only to the steadily increasing sales of CARTISTEM® but also supply overseas clinical trial demands followed by an aggressive market entry plan.
An official of MEDIPOST said, “We have preemptively expanded GMP facilities in consideration of the demands for CARTISTEM® in Korea and foreign countries such as Malaysia, which is expected to increase in the post-pandemic market, and also overseas clinical trial demands such as those in Japan. We’re also planning to complete GMP certification by 2023,” and,
“The new GMP facility was designed to provide the latest installations and production environment in preparation for conversion to commercial production. We’ll start commercial production of next-generation stem cell SMUP-Cell pipeline products such as SMUP-IA-01 (an injectable drug for knee osteoarthritis) and SMUP-IA-01 (intravenous injection for acute respiratory distress syndrome) once Korean and international clinical trials are completed.”
With the enforcement of the Advanced Regenerative-Bio Act, MEDIPOST plans to complete the process of obtaining the license for manufacturing advanced biological products for the existing GMP facilities by August this year, separate from the new GMP facility.