Medipost Advances Quality Enhancement with Support from MFDS

Exterior view of Medipost headquarters in Pangyo, Seongnam-si, Gyeonggi-do (Photo by Medipost)

[Asia Economy Reporter Chunhee Lee] Medipost announced on the 25th that it has been selected as a target company for customized QbD technology consulting support, conducted as part of the "Establishment of a Foundation for the Introduction of Quality by Design (QbD) System for Pharmaceuticals" project supported by the Ministry of Food and Drug Safety and operated by the Korea Innovative Medicines Consortium (KIMCo).

The QbD approach integrates and unifies manufacturing processes and quality control, operating based on scientifically and statistically verified manufacturing and quality management designed through risk assessment. Advanced pharmaceutical countries such as the United States and Europe already operate QbD systems, and other countries are expanding the adoption of QbD systems. Accordingly, as the number of countries worldwide requiring QbD data increases, the Ministry of Food and Drug Safety has been continuously conducting consulting support projects for pharmaceutical and bio companies since 2020 to introduce the QbD system domestically.

After applying for the QbD consulting support project in June, Medipost was finally selected and will receive customized QbD technical support for cell therapy products for about three months. The company explained that since cell therapy products are manufactured using living cells, it is difficult to standardize and establish the production process unlike other pharmaceuticals, and there are almost no models or cases applying QbD, making this selection for the QbD consulting support project meaningful. In particular, the company plans to use this opportunity to apply QbD to all cell therapy products to improve production processes and quality, enhance international competitiveness, and accelerate overseas expansion.

A Medipost official said, “Through this support project, we expect to apply and utilize a QbD model suitable for domestic conditions in the development and commercialization of cell therapy products,” adding, “By establishing a QbD application model for cell therapy products, we will provide guidance to the domestic cell therapy market and contribute to enhancing the global competitiveness of domestic biopharmaceutical development companies.”