Korea Bio Association Conducts Training on Pharmaceutical Process Development and Quality Control

The Korea Bio Association announced on the 7th that it held the ‘Biopharmaceutical CMC Academy 2024’ training for understanding the current status of the biopharmaceutical industry and the entire research and development process over three days from the 31st of last month to the 2nd at the Suwon Convention Center in Suwon, Gyeonggi Province. CMC stands for Chemistry, Manufacturing, and Controls, referring to process development and quality control tasks necessary for drug production.

The Korea Bio Association recently announced that it held the 'Biopharmaceutical CMC Academy 2024' at the Suwon Convention Center.
[Photo by Korea Bio Association]

This training was attended by 57 trainees of various ranks, ranging from practical to manager levels, from bio ventures and large pharmaceutical companies. Dr. Ko Yeowook, former head of the R&D Institute at Chongkundang Hyojong Bio, served as the instructor, sharing over 30 years of accumulated know-how in the CMC research and development field.

The curriculum consisted of ▲biopharmaceutical industry trends ▲biopharmaceutical research and development processes ▲major items by biopharmaceutical classification. The focus was on enhancing the capabilities of researchers, research planning and project management, and regulatory affairs personnel. Practical bio CMC training covered raw material drugs (DS) and finished product drugs (DP) manufacturing processes, new drug development, process development, non-clinical, clinical, and Good Manufacturing Practice (GMP) production approval stages. In particular, virtues and know-how for successful workplace life were introduced based on vivid field experiences, receiving great responses. On the last day of training, one-on-one consulting and exchanges among trainees were held to share concerns and advice.

The trainees said, “There were many tasks in the field that were similar to what we learned in degree programs but unfamiliar, causing difficulties, but through this training, we were able to grasp the overall framework for setting CMC guideline items for advanced biopharmaceuticals,” and “The case-centered lectures with field relevance made us think about how to apply them in actual work.” Other responses included, “The time to learn key virtues for successful workplace life was very helpful.”

Son Jiho, Executive Director of the Industry Support Headquarters at the Bio Association, said, “Interest was so high that we recruited more than twice the number of trainees originally planned for this training,” and added, “We will plan various training topics needed in the field through education demand surveys.”

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