GC Cell Participates in Ministry-Led "On-site Customized Consulting for Advanced Biopharmaceutical CDMOs"

Discussing Ways to Enhance Quality Competitiveness in Advanced Biopharmaceuticals

GC Cell announced on June 4 that it participated in the "On-site Customized Consulting for Advanced Biopharmaceutical CDMOs," hosted by the Cell and Gene Therapy Division of the Biopharmaceuticals and Herbal Medicines Review Department at the Ministry of Food and Drug Safety, on May 28.

This program, which the Ministry of Food and Drug Safety began piloting this year, is a regulatory support initiative focused on on-site visits. It selects five domestic advanced biopharmaceutical CDMO companies and visits them directly, aiming to listen to difficulties encountered at the field level during the work processes between contract givers and contract acceptors, and to seek practical institutional improvement measures together.

In addition to GC Cell, representatives from major contract givers collaborating with GC Cell also attended the consulting session. The participating companies shared various field-level challenges encountered in the advanced biopharmaceutical CDMO contract process, such as GMP operations, quality responsibility systems, technology transfer, test method operations, and utilization of manufacturing facilities.

In response, the Ministry of Food and Drug Safety presented opinions on practical considerations and directions for improvement based on the CMC (quality) requirements and GMP management principles for each stage of advanced biopharmaceutical development. The session also included discussions on ways for contract givers and contract acceptors to jointly enhance quality competitiveness.

GC Cell and other participating companies stated that the answers and explanations provided by the Ministry allowed them to gain a clearer understanding of the quality management directions and regulatory expectations to be considered when conducting CDMO business. They also expressed expectations that this would contribute to improving the quality standards of the advanced biopharmaceutical industry and securing global competitiveness.

A GC Cell representative said, "This on-site consulting session was a meaningful opportunity for regulators, contract givers, and contract acceptors to communicate and discuss the direction for advancing the biopharmaceutical industry. Going forward, we will continue to grow as a trusted CDMO partner for clients and patients by leveraging our global-level quality systems and manufacturing capabilities."

This content was produced with the assistance of AI translation services.