- Course to educate 230 trainees from 33 LMICs and 42 Koreans on GxP to bridge basic knowledge and hands-on training to produce skilled personnel in biomanufacturing
October 31, 2022, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) kicked off the ‘Introductory Course for Standard Practice (GxP Course)’ on October 31 at Seoul National University’s Shiheung Campus to train 230 trainees from 33 low- and middle-income countries (LMICs) and 42 from Korea.
The GxP course offers professional training on international standard 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 GxP)’ and the basics of biosafety.
The three-week course started with the Opening Session at Seoul National University’s Shiheung Campus Hotel & Convention Center in Shiheung City, Gyeonggi Province on October 31. In attendance at the event were trainees and IVI Director General Dr. Jerome Kim, who joined virtually to give his welcome remarks.
Fifteen experts from around the world, including IVI, CEPI, Bill & Melinda Gates Foundation, and industry will serve as faculty members for the course.
Most didactic training will take place at the SNU Shiheung Campus and the Ansan Training Center in Gyeonggi. The course, which will continue through November 18, also features field trips to biomanufacturing facilities of public organizations (including Public CMO for Microbial-based Vaccine in Hwasun, Animal Cell Culture Substantiation Center in Andong, and K Bio Health Center in Osong), as well as leading vaccine and biotech companies across Korea on November 4 and 11.
Through these activities, the new course aims to equip the participants from LMICs with essential skills required for operation according to good biomanufacturing practices. Hence, the course, conducted offline (in person), is targeting technicians, engineers or managers of bio companies and organizations and those currently involved in the production of bioproducts including vaccines, therapeutics, and monoclonal antibodies.
Trainees were selected in consultation with the WHO, while trainees from Korea include staff from vaccine and biopharmaceutical firms and graduate students of related fields. The trainees who meet the necessary requirements will be awarded a certificate of completion presented jointly by the Korean Minster of Health and the IVI Director General during the Closing Ceremony on November 18.
“At the end of the training, all participants will be equipped with essential knowledge and skills required to operate a biomanufacturing facility according to international standards,” said Ms. Alice Lee, the course’s coordinator and head of IVI’s Business Development.
The GxP course, the first of its kind for LMICs in the world, has been organized by IVI in collaboration with the WHO and MOHW, which provides funding support for biomanufacturing training to help strengthen LMICs’ capabilities in local production of vaccines and biopharmaceuticals, address vaccine inequity and enhance pandemic preparedness.
The GxP course is the second biomanufacturing training course to be conducted after Korea was designated by the WHO as Global Training Hub for Biomanufacturing (GTH-B) in February. One of the important resource gaps identified through the pandemic by many experts in enabling local vaccine manufacturing is the availability of skilled, trained personnel in this highly advanced technology field. To support countries trying to fill this resource gap, MOHW launched GTH-B with support from the WHO.
“Korea, as the GTH-B country, seeks to lay the foundation for fighting the pandemic by nurturing vaccine and drug manufacturing manpower around the world,” Dr. Hyun-joon Kim of MOHW said in his welcome remarks.
As an operator of GTH-B, IVI successfully conducted the ‘2022 Introductory Course for Biologics Development and Manufacturing’ in July to train 106 participants from 24 LMICs and 32 from Korea.
IVI Director General Dr. Jerome Kim said, “The GXP training builds on and supplements July’s course. Making most of Korea’s robust biomanufacturing capacity and training infrastructure, IVI will provide quality GXP training to strengthen LMICs’ crucial capabilities in biomanufacturing and empower LMICs to increase local production of vaccines and biologicals.”
The GxP course consists of lessons on the theory of practice and standards, tests for clinical trial certification, case studies by group, and a business convention with Korean vaccine and biopharmaceutical companies, as well as field trips to production facilities. Through the GxP training, trainees learn the details of certification standards throughout the production process, including equipment, raw materials, manufacturing, and packaging for vaccine and biopharmaceutical production.
These standards on drug and vaccine development, production and approval are essential requirements for ensuring the efficacy of drugs and vaccines and minimizing potential side effects. It is mainly administered by regulatory agencies in each country, such as the US Food and Drug Administration, and the Korean Ministry of Food and Drug Safety.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.
IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO), and developed a new-generation typhoid conjugate vaccine that is currently under assessment for WHO PQ.
IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, and Finland provide state funding. For more information, please visit https://www.ivi.int.
Aerie Em, Global Communications & Media Specialist
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