Company
Business
Stem Cell Therapy
Organoid
CDMO Business
PR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Gyeongin Regional Food and Drug Administration Commendation Award
20
2024.12
Kangstem Biotech was awarded the Gyeongin Provincial Food and Drug Safety Commissioner's Commendation at the 2024 Food and Drug Safety Management Meritorious Commendation Ceremony on the 19th.
Kangstem Biotech was awarded the Gyeongin Provincial Food and Drug Safety Commissioner's Commendation at the 2024 Food and Drug Safety Management Meritorious Commendation Ceremony on the 19th. This ceremony, organized by the Ministry of Food and Drug Safety(MFDS), aims to raise awareness of the importance of food and drug safety management among companies and industries.
We are conducting the cell-gene therapy(CGT) CDMO business under the certification of the Stem Cell GMP Center's human cell management business. In particular, we are contributing to the rapid entry of our clients into clinical trials by establishing GMP documents and optimizing production processes based on an advanced quality system. Additionally, we have been certified as an advanced regenerative medical cell processing facility, which allows us to supply both allogeneic and autologous stem cells to regenerative medical institutions, positioning us for the launch of the advanced regenerative medicine business in Korea next year.
In addition, we have introduced a laboratory information management system (LIMS), basic data management system (RDMS), and electronic note system (ELN) with the goal of data integrity that meets global regulations and standards for technology export and overseas clinical trials, such as OSCA, a fusion treatment for osteoarthritis. This enables automatic storage and management of data and computerization of experimental records, enabling efficient management of data without paper documents and ensuring data completeness, accuracy, and consistency, thus equipping the company with the capability to enter the global market.
At the award ceremony, the company was recognized for its contributions to: ▲compliance with the Advanced Biopharmaceuticals Act, ▲management of human cells, etc. and certification and maintenance of cell processing facilities, and ▲building and securing data integrity by introducing the LIMS system.
The Director of the Stem Cell GMP Center stated, “Our stem cell GMP center is systematically managing the entire facility and manufacturing process, including aseptic production, cell storage, and quality control. This recognition as a best practice by the KFDA is a testament to our efforts. Next year, we plan to complete the construction of a data integrity system that meets both domestic and international drug manufacturing and quality control standards. By finalizing stabilization tests, such as the ongoing LIMS operation simulation, we will enhance data reliability, improve test management, increase work efficiency, and secure global competitiveness through the full implementation of this system.”
https://www.fnnews.com/news/202412200859367126