In this regard, Lee further explained that course participants underwent a nine-hour pre-course lecture to better prepare them for the three-week training program. She added that after this course, they expect participants to be able to enter GMP facilities for manufacturing or preparing vaccines. Offering further insights into the program, IVI’s business development director Alice Lee shared, “We are very thankful for the support from Korean bio companies regarding license out and transfer training, as well as assay qualification and validation which helps us attain our final goal of training for vaccine self-sufficiency in LMICs.” Among the 30 participating companies were HK inno.N, Cytiva, Doosan, and SD Biosensor. The companies that delivered IR presentations also mentioned the opportunity for communication and collaboration with participants and their countries. Participants of the 2022 Introductory Training Course for Standard Practice (GXP) engage in discussions with Korean companies regarding their standard manufacturing processes and future business collaborations. During the IR session, the companies introduced their mission to contribute to the present and future of the global bio-industry. Sixteen of these companies participated in the one-hour IR session at the Seoul National University, Siheung Campus. Meanwhile, earlier on Tuesday, IVI also hosted a mini-convention as part of the training program where approximately 30 Korean bio companies were specially invited for poster presentations. However, it was “eye-opening” to see how Celltrion was able to safely manage and operate the big-scale factory and the corresponding standards, she added. Reihaneh Mirhassani, an R&D manager at Nivad from Iran, said she was very familiar with factory settings as she works in a laboratory. She highlighted clean-in-place (CIP), steam-in-place (SIP), and ISO-grade standards used throughout the factory from media buffer preparation straight through to the fill and finish process. The Celltrion factory tour was led by Celltrion’s manufacturing division director Lee Kyung-jin who elaborated on the antibody drug manufacturing process and GMP production facility operation. To adequately facilitate all 272 participants in the factory site visits on Friday, participants were split into six teams to visit Celltrion, Samsung Biologics, GC Pharma, CHA Vaccine Bio, Satorius and Korea University School of Medicine. “Currently, our two factories mainly do the manufacturing of Celltrion products but with the addition of the third plant, we will be able to take on other CMO projects as well,” said Kim. Kim Min-soo, head of Cell Engineering, Research and Development Division, Biotechnology Research Division, before touring Celltrion’s factory in Songdo, Incheon on Friday. Participants of the 2022 Introductory Training Course for Standard Practice (GXP) listen to an introductory lecture by Dr. However, Celltrion is also keen to differentiate its business model by focusing on producing higher titters and attracting smaller CMO businesses with their third plant. He also mentioned plans to expand further its business into generics and digital healthcare.Ĭelltrion plans to finish building its third factory by November 2023, apparently keeping pace with Samsung Biologics. Kim Min-soo, head of Cell Engineering, Research and Development Division at Celltrion introduced the company’s biosimilars - Remsima, Herzuma, Truxima, Yuflyma, and Vegzelma. The trainees were provided with professional training on the international standards of quality for vaccine and biomedical product development and manufacturing known as Good Clinical, Manufacturing and Laboratory Practice, and Clinical Laboratory Practice (GCP, GMP, GLP, GCLP – collectively referred to as GxP), including the basics of biosafety.Įxplaining Celltrion’s goal to seek regulatory approval of a biosimilar product every year, Dr. The ongoing course has 272 trainees in total - 230 from 33 different low- and middle-income countries (LMICs) and 42 from Korea. This training program is the second WHO GTH-B program following the first course in standard biomanufacturing in July which trained 106 foreigners and 32 Koreans. Some participants of the 2022 Introductory Training Course for Standard Practice (GXP) pose infront of the photozone after the mini-convention at the Seoul National University, Siheung campus on Tuesday.
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