IVI conducts 2024 Introductory Course for Standard Practice (GxP) to strengthen manufacturing capabilities of high-quality vaccines and biologics in LMICs
October 29, 2024, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) has kicked off the 2024 Introductory Course for Standard Practice (GxP Course), aimed at enhancing the quality management of biomanufacturing in low- and middle-income countries (LMICs) through specialized human resources training at Seoul National University’s Siheung Campus. Running from October 29 to November 14, 2024, this intensive three-week program will train 183 participants from 42 countries and 13 from Korea. The course aims to address global vaccine inequities and bolster international efforts to combat infectious diseases by building LMIC’s biomanufacturing capabilities. Now in its third edition, the annual GxP Course is hosted by the Korean Ministry of Health and Welfare (MoHW) and the Global Training Hub for Biomanufacturing (GTH-B) Support Foundation and organized by IVI as part of the GTH-B program. GTH-B, launched in 2022, is a joint initiative of the Korean MoHW and the World Health Organization that seeks to empower LMICs to produce vaccines and biologics locally by strengthening their biomanufacturing capabilities. The opening ceremony of this year’s GxP course was attended by Dr. Manki Song, Deputy Director General of Science; Mr. Dong Hyun Kim from MoHW, and Dr. Hyun Joo Yang, Secretary General of the GTHB Support Foundation, as well as the trainees. The GxP Course features a faculty team of 27 international experts from nine leading institutions, including IVI, Nagasaki University in Japan, and Instituto Butantan in Brazil. The curriculum covers critical aspects of biomanufacturing, including Good Clinical, Manufacturing, Laboratory, and Clinical Laboratory Practices (GCP, GMP, GLP, GCLP—collectively known as GxP), as well as biosafety protocols to ensure safe and effective manufacturing. Trainees include professionals from companies and organizations involved in the development and production of biopharmaceuticals such as vaccines, therapeutics, and monoclonal antibodies in LMICs, as well as technical personnel from bio manufacturers and graduate students from Korea. After completing the course, they are expected to work in the field of vaccine development and manufacturing and immunization at companies, organizations and the government in their respective countries. The course is offered free of charge, excluding travel expenses. To support African participation, travel scholarships have been awarded to 12 trainees by the East African Community Regional Centre of Excellence for Vaccines, Immunization, and Health Supply Chain Management (EAC RCE-VIHSCM) in Rwanda. Specifically, this course is designed to equip countries with the knowledge and skills needed to meet the international standards of GCP, GMP, GLP, GCLP and biorepository, and biosafety for vaccine and biologics development and production. To this end, the curriculum includes a series of didactic lectures and practical and hands-on training designed to give a comprehensive overview and insights into the biomanufacturing process, from raw material management to packaging and regulatory compliance. The trainees will also have a chance to tour leading biomanufacturing sites in Korea to gain practical experience and network with industry experts, with field visit activities increasing from one day to two days this year in response to suggestions by trainees of previous courses. Since 2022, IVI’s GTH-B program has trained approximately 800 professionals through its various courses, including three editions of the ‘Introductory Course for Biologics Development and Manufacturing,’ two GxP courses, plus nine onsite consultations in LMICs. These courses combine class lectures, practical and hands-on training, and field visits to Korea’s leading biotech companies to deliver an immersive learning experience. Dr. Jerome Kim, Director General of IVI, “With its world-class bioindustry, robust training infrastructure and the government’s commitment, Korea’s leadership in global biomanufacturing training is truly exemplary. IVI is grateful and privileged to partner and synergize with Korea in advancing these vital initiatives for vaccine equity and global health.” Ms. Alice Lee, Director of IVI’s Business Development who leads its GTH-B program, said, “Since 2022, GTH-B has been a critical driver in addressing the global need for skilled biomanufacturing personnel, providing essential training and support to enable sustainable vaccine production in LMICs. The GTH-B Support Foundation and the forthcoming Global Bio Campus as a dedicated training facility will help further solidify Korea’s leadership in strengthening biomanufacturing capabilities in LMICs.” ### 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 also achieved WHO prequalification in early 2024. IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, an Africa Regional Office in Rwanda, a Country Office in Austria, and a Country and Project Office in Kenya. IVI additionally co-founded the Hong Kong Jockey Club Global Health Institute in Hong Kong and hosts Collaborating Centers in Ghana, Ethiopia, and Madagascar. 42 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, Austria, and Thailand provide state funding. For more information, please visit https://www.ivi.int.
IVI to conduct ‘2024 Introductory Course for Biologics Development and Manufacturing’ to help address global vaccine inequity
June 3, 2024, SEOUL, Republic of Korea — International Vaccine Institute (IVI) announced it will conduct the ‘2024 Introductory Course for Biologics Development and Manufacturing’ as part of the Global Training Hub for Biomanufacturing (GTH-B) program at Seoul National University’s Siheung Campus for two weeks starting June 3. The program, hosted by the Ministry of Health and Welfare (MOHW) jointly with the World Health Organization (WHO), aims to strengthen vaccine production capacity in middle- and low-income countries and Korea. The course, which will start with an opening ceremony at 10 a.m. on the first day, brings together 155 trainees from 49 countries, including employees of vaccine companies and organizations, as well as 20 trainees from Korean biotechs and graduate students specializing in the bio sector. The trainees have been selected through a committee led by MOHW and WHO and will receive comprehensive training, including didactic education on the entire vaccine production cycle, discussions, case studies, field trips to companies and organizations, and networking with industry professionals. Thirteen African participants have received travel support from the East African Center for Excellence in Vaccines, Immunization and Health Supply Chain Management (EAC RCE VIHSCM) in Rwanda. The course will be taught by a faculty team of over 40 experts from more than 10 institutions, including international organizations such as IVI and the Coalition for Pandemic Preparedness Innovation (CEPI), government agencies such as the UK’s National Institute for Biological Standards and Control (NIBSC), Korea’s Ministry of Food and Drug Safety and the Korea Disease Control and Prevention Agency, and vaccine companies. Dr. Jerome Kim, Director General of IVI, will deliver a keynote lecture on “The History and Development of Vaccine Technology” following the opening ceremony. The course will be conducted as in-person training for two weeks, following 12 hours of preparatory online training. It will cover the full cycle of vaccine research and development, production, and use, including immunology, vaccine technology, product development, preclinical and clinical development, health economics, intellectual property, and regulatory affairs. There will also be a ‘Mini convention’ for networking with Korean biotech companies and field trips to production facilities of leading biotech firms and related organizations. Through this comprehensive training, IVI aims to ensure that all trainees who have completed this course have mastered the essential theories and are equipped with the practical knowledge and skills necessary to operate a biomanufacturing facility. GTH-B was established by MOHW and WHO in February 2022 to address global vaccine inequities revealed by the COVID-19 pandemic and to create a world safer from infectious diseases. While promoting equitable vaccine access in LMICs, the GTH-B program also aims to improve Korea’s global biohealth leadership as a hub for fostering biomedical human resources in LMICs by establishing a collaborative system with international organizations such as WHO and regional development banks, and by promoting the global biologics and vaccine industry. IVI was selected by MOHW as the operator of GTH-B’s ‘Global Bio Intensive Training Courses’ in 2022 and has since implemented ‘the Introductory Course for Biologics Development and Manufacturing’ and ‘the Introductory Course for Standard Practice (GxP Course).’ It has also conducted seven overseas on-site consulting and training, including two in South Africa and one each in Bangladesh, Kenya, Senegal, Ghana, and Nepal. IVI has thus trained a total of 870 people in-person through GTH-B and related courses, and more than 2,100 through online training in the past two years. The institute plans to educate over 300 people this year through a variety of GTH-B courses, including didactic and hands-on courses and onsite training and consultations in LMICs. Eun-young Jeong, Director General of the Health Industry Policy Bureau at MOHW, said at the opening ceremony, “We hope that this training will greatly contribute to strengthening vaccine production capabilities in LMICs and advancing global health security. The ministry will operate various curricula including didactic and practical training for foreign and domestic bioindustry workforces and offer onsite consulting overseas and online training based on excellent education programs and Korean companies to enable Korea to play a responsible role as a biohealth hub.” Dr. Jerome Kim, Director General of IVI, said, “Through GTH-B, IVI is contributing to addressing the global vaccine gap by providing quality education that leverages Korea’s excellent bio-infrastructure and IVI’s demonstrated capabilities. To make this happen, IVI will continue to closely collaborate with MOHW, WHO and other partners around the world.” 【Trainees for 2024 Introductory Course for Biologics Development and Manufacturing by Nationality】 * (Total 175) Ghana (2), Nigeria (1), South Sudan (2) South Africa (1), South Korea (20), East Timor (1), Rwanda (2), Malawi (1), Malaysia (8), Mexico (1), Mozambique (1), Montenegro (5), Mongolia (3), Bangladesh (5), Vietnam (2), Botswana (2), Burundi (4), Brazil (6), Senegal (1), Serbia (4), Sri Lanka (2), Azerbaijan (2), Albania (1), and Angola (1), Ethiopia (5), Jordan (2), Uganda (4), Uzbekistan (2), Ukraine (1), Iran (2), Egypt (8), India (2), Indonesia (4), Zambia (1), China (16), Zimbabwe (3), Cameroon (4), Kazakhstan (6), Kenya (2), Côte d’Ivoire (1), Colombia (1), Congo (1), Kyrgyzstan (2), Tanzania (9), Thailand (6), Tunisia (1), Paraguay (1), Pakistan (5), Peru (1), and the Philippines (7). Source: Ministry of Health and Welfare, Republic of Korea ### 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 also achieved WHO prequalification in early 2024. IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, an Africa Regional Office in Rwanda, a Country Office in Austria, and a Country and Project Office in Kenya. IVI additionally co-founded the Hong Kong Jockey Club Global Health Institute in Hong Kong and hosts Collaborating Centers in Ghana, Ethiopia, and Madagascar. 41 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.
IVI conducts ‘2023 Introductory Course for Standard Practice (GxP Course)’ to support LMICs in local biomanufacturing
October 30, 2023, SEOUL, Republic of Korea — The International Vaccine Institute (IVI) is conducting the Introductory Course for Standard Practice (GxP Course) for a total of 180 participants, including 148 trainees from 44 low- and middle-income countries (LMICs) and 32 Koreans, for three weeks from October 30. Hosted by the Ministry of Health and Welfare, Republic of Korea, and organized by IVI, the course is taking place at the Nest Hotel in Yeongjongdo, Incheon, and Seoul National University’s Siheung Campus. At the opening ceremony, IVI Director General Dr. Jerome Kim delivered a keynote lecture on “IVI and Proposal for the African Vaccine Alliance (AVA)” to address the need and efforts to support regional vaccine manufacturing in the continent on October 30. The course will be presented by a team of 17 experts from 8 institutions worldwide including IVI, the Hillelman Laboratories in Singapore, and the University of Texas at Austin. The GxP course aims to address vaccine inequalities and strengthen the global response to infectious diseases by supporting LMICs in enhancing their capacities in quality management of biomanufacturing through human resources training. The course will educate the trainees 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. Trainees include professionals from companies and organizations involved in the development and production of biopharmaceuticals such as vaccines, therapeutics, and monoclonal antibodies in LMICs, as well as technical personnel from bio manufacturers and graduate students from Korea. The Partnerships for African Vaccine Manufacturing (PAVM) of the Africa Centres for Disease Control and Prevention (CDC) has provided travel scholarships to 24 trainees from African countries, and the East African Community Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (EAC RCE-VIHSCM) based in Rwanda has supported another group of 15 trainees for travel. The course will cover certification standards (GMP, etc.) for the entire production process, including production facilities, raw materials, manufacturing, and packaging in compliance with the stringent regulatory standards of the Korean Ministry of Food and Drug Safety. In addition to class lectures, the course will also include field visits to advanced vaccine and drug production facilities of leading biomanufacturers, providing trainees an opportunity to network with companies in Korea. The course is part of the Global Training Hub for Biomanufacturing (GTH-B) program, which IVI has been implementing for LMICs in collaboration with the Ministry of Health and Welfare since last year. LMICs continue to face serious inequalities in access to vaccines and biopharmaceuticals and are endeavoring to establish a local biomanufacturing base in their countries. In February last year, the World Health Organization (WHO) designated Korea as the GTH-B to empower LMICs to produce their own vaccines in a sustainable fashion by providing crucial biomanufacturing training, thereby easing global vaccine inequalities and boosting global pandemic preparedness. Subsequently, IVI was designated by MOHW as an operator of GTH-B courses, Korea’s flagship bio workforce training program. In addition, the WHO designated South Africa as an ‘mRNA Vaccine Technology Transfer Hub’ last year to promote the expansion of local production of vaccines in different countries. However, countries’ efforts to build manufacturing capacity through bilateral technology transfer or local R&D are often hampered by a lack of trained and skilled workforces. To assist countries in overcoming this challenge, the Korean Ministry of Health and Welfare, with the support from the WHO, has established the GTH-B. “Korea has an excellent biological training infrastructure combined with world-class companies boasting excellent biomanufacturing capabilities, and the government is committed to promoting the vaccine and bio industry, investing in R&D, and supporting LMICs,” said IVI Director General Dr. Jerome Kim. “In addition, the Ministry of Food and Drug Safety has established itself as a top-notch regulatory agency, making Korea an ideal environment as a training site for quality biomanufacturing management.” Strengthening vaccine-related capacity in LMICs is a key priority of IVI’s mission. As the only international organization devoted to the discovery, development and delivery of vaccines for global health, IVI has experience and the necessary capabilities to provide quality training in vaccine R&D, technology transfer, biomanufacturing and capacity building. Since 2000, IVI has conducted 22 editions of its annual International Vaccinology Course, providing training to more than 5,000 professionals worldwide. Building on this, IVI has run two editions of ‘Introductory Course for Biologics Development and Manufacturing’ last year and this year, and one ‘GxP course’ to provide GTH-B training to about 500 people in more than 40 countries, plus overseas on-site consulting and training in several countries including Bangladesh and South Africa.
IVI conducts 2nd Introductory Course for Biologics Development and Manufacturing for 235 trainees from 47 LMICs
June 19, 2023, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) is conducting the 2023 Introductory Course for Biologics Development and Manufacturing for bio-R&D and production personnel from low- and middle-income countries (LMICs). The course, the second of its kind, is hosted by the Korean Ministry of Health and Welfare (MOHW) and organized by IVI to support LMICs in strengthening their biomanufacturing and infectious disease response capabilities by training human resources and to address global vaccine inequity. The course started with a kickoff ceremony at Seoul National University Siheung Campus in Gyeonggi Province on June 19 and will conclude on June 30. 235 trainees are participating in the course, including 205 from 47 LMICs and 30 from Korea, focusing on the theme: Technology transfer, talent development and facility management, and aseptic processing. The trainees are early-career professionals with 6 years or less of experience in private companies in the vaccines and therapeutics field, as well as participants from government and public organizations in LMICs including those participating in the mRNA technology transfer program led by WHO and the COVAX Facility. The course is offered free of charge (excluding travel expenses) with MOHW’s support. The 30 Korean trainees include officials from industry and students from universities who seek to broaden their professional skills, knowledge, and global networking experience. The course covers the full cycle of vaccine research and development, production, and use, including immunology, vaccine technology, product development, preclinical and clinical development, quality control, intellectual property, product licensing, and vaccination, and features special lectures and case studies. The course is taught by a faculty team of more than 40 experts from over 15 organizations around the world, including IVI, WHO, CEPI, the Korea Disease Control and Prevention Agency’s National Institute of Health, Karolinska Institutet in Sweden, and the Wellcome Trust in the United Kingdom. The course was prefaced by a week-long pre-training followed by the two-week offline training. This also includes a ‘Mini Convention’ for networking with Korean bio companies and field trips to leading bio companies and institutions in the country. As in the previous course last year, IVI aims to ensure that by the end of the training, all trainees will have mastered the basic and essential theories and gained the practical knowledge and skills necessary to operate a biomanufacturing facility. The course is part of the Global Training Hub for Biomanufacturing (GTH-B) that IVI has been implementing in collaboration with MOHW since last year. In February 2022, IVI was designated by MOHW as the operator of the ‘Global Bio Intensive Training Courses,’ a workforce training program supported by the Korean government to address global vaccine inequity and strengthen pandemic preparedness. At the time, Korea was designated by WHO as the world’s only GTH-B tasked with providing training to help LMICs sustainably produce their own vaccine and biologicals. Facing significant inequalities in access to vaccines and biopharmaceuticals, LMICs have been stepping up efforts to establish a biopharmaceutical manufacturing base in their countries. Last year, WHO designated South Africa as an mRNA vaccine technology transfer hub to promote local production of vaccines in LMICs. However, efforts to build this manufacturing capacity, whether through bilateral technology transfer or local R&D, have been hampered by the lack of a trained workforce. To help countries overcome these challenges, MOHW established the GTH-B with the support of WHO and the WHO Academy. In his congratulatory remarks, Seung-hyun Hwang, Director General of the Global Vaccine Hub Office at MOHW said, “I hope this training will contribute to improving vaccines and biopharmaceuticals manufacturing capacities in LMICs.” He added, “In the second year of the GTH-B initiative, Korea will spare no effort to build infrastructure such as the Global Bio Campus, expand practical training, and cooperate with international organizations to foster a sustainable global vaccine manufacturing workforce.” Strengthening vaccine-related capacities in LMICs is a core part of IVI’s mission. As the only international organization dedicated to the discovery, development, and delivery of vaccines for global health, IVI has robust experience and capabilities to provide quality training in vaccine R&D, technology transfer, biomanufacturing and capacity building. Since 2000, IVI has organized the IVI International Vaccinology Course annually to train a total of more than 3,000 professionals worldwide. Korea has globally competitive bio companies with excellent manufacturing capabilities in addition to a strong training infrastructure and a government committed to developing the nation’s bio industry while supporting LMICs. Dr. Jerome Kim, Director General of IVI, said, ”Through the GTH-B project, we are synergizing Korea’s excellent bioindustry infrastructure with IVI’s demonstrated capabilities to provide high-quality biomanufacturing training. To help increase local production of vaccines and biopharmaceuticals in LMICs and address the global vaccine access gap, IVI will continue to collaborate with MOHW, WHO, and Korean and global industry partners.” Last year, IVI trained a total of 325 people through the first Introductory Course for Biologics Development and Manufacturingand Introductory Course for Standard Practice (GxP). The institute also conducted three overseas on-site training sessions, including one in Bangladesh and two in South Africa. Additionally, IVI just completed GTH-B on-site consulting in Kenya in late May of this year and will conduct the second Introductory Course for Standard Practice this fall. ### 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, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.
IVI conducts 1st Introductory Course for Standard Practice (GxP Course) Oct. 31 – Nov. 18
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. CONTACT Aerie Em, Global Communications & Media Specialist+82 2 881 1386 | aerie.em@ivi.int
First ‘Introductory Course for Biologics Development and Manufacturing’ completes training of 106 participants from 24 countries, and 32 Koreans
July 29, 2022, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) successfully completed the ‘2022 Introductory Course for Biologics Development and Manufacturing’ on July 29 to train 106 participants from 24 low- and middle-income countries (LMICs) and 32 from the Republic of Korea. The two-week course took place in Seoul, Korea with funding support from the Korean Ministry of Health and Welfare from July 18–29 to help strengthen LMICs’ capabilities in local production of vaccines and biologics, address vaccine inequity, and enhance pandemic preparedness. Trainees were mostly vaccine manufacturing personnel and officials from governments and public organizations from recipient countries of the ‘mRNA technology transfer hub,’ designated by the World Health Organization, and LMICs with vaccine production facilities. Trainees from Korea included employees from vaccine and biopharmaceutical companies and graduate students majoring in related subjects. The trainees gained essential skills and competencies needed to respond to future infectious disease threats through basic education on the entire cycle of vaccine development, production, and licensing, as well as practical knowledge in relevant subjects, including vaccine-related health environment and policies, patents and intellectual property rights. Also, the trainees took field trips to advanced manufacturing and R&D facilities for vaccine and pharmaceuticals and clinical trial sites to take a first-hand look at manufacturing and R&D processes at nine leading Korean companies and organizations. They include Celltrion, Samsung Biologics, Cytiva, Yonsei University K-NIBRT, GC Biopharma, Sartorius Korea, Seoul National University (SNU) Hospital, SNU College of Pharmacy, and Korea University College of Medicine. Dr. Samia Rourou, Head of Biotech Development Lab at Institute Pasteur Tunisia, said, “I am from biotech development, so originally from the lab. Through this course, I was able to gain a general overview of vaccines and expand my knowledge to areas that were not my area of expertise. The course is very well structured and has invited experts from all fields as lecturers. Visits to labs and factories are also very interesting. This course really enhances us to go further from the primary baseline we are at.” Dr. Rohaida Hashim, a senior researcher at the National Institute of Health, Ministry of Health of Malaysia, said, “The course is very extensive and informative. I hope in the future there would be more courses like this so my colleagues from my country can also attend, to get all the knowledge and learn the technology that Korea has. So, we can bring back the knowledge and transfer it to our organizations.” The trainees were awarded a certificate of completion signed jointly by the Korean Minster of Health and the IVI Director General during the Closing Ceremony on July 29. Notably, Partnerships for African Vaccine Manufacturing (PAVM) of the Africa Centres for Disease Control and Prevention (CDC) provided travel scholarships to 50 trainees from 14 African countries out of 106 trainees from 24 LMICs participating in the course. “The launch of the first cohort of the PAVM Scholarship represents an important milestone in the PAVM’s ambition to upskill manufacturing talent in the African continent. Participants come from a wide array of backgrounds and were selected in a competitive process, which included their commitment to advance vaccine manufacturing in their home institutions and in their respective countries” said Dr. Nicaise Ndembi, Head of the Science Office at the Africa CDC and Lead of the PAVM Secretariat. Everest Okeakpu of Nigeria, Chief Operating Officer of Biovaccine Nigeria Limited, a joint venture for local vaccine manufacturing, said, “By 2024, we will finish building a facility in Nigeria to start local fill & finish for some of the EPI vaccines that are of importance to Nigeria. With the introduction of the mRNA hub, it is possible to incorporate all of this knowledge in the planning, and to integrate what you need into a short-term, medium-term, long-term plan.” In June last year, the WHO established the first mRNA technology transfer hub in South Africa to help increase local production of vaccines and biologics, and picked 15 countries worldwide as recipients of mRNA technology transfer by July this year. However, new production facilities require the deployment of a skilled workforce amenable to general bio-manufacturing processes. To help meet this need and support LMICs in producing vaccines and biologics locally, the WHO established the Global Training Hub for Biomanufacturing (GTH-B) in Korea, a country equipped with robust biomanufacturing infrastructure and capacity. The Introductory Course for Biologics Development and Manufacturing is the first in the 2022 Global Bio-Intensive Training Courses series for the GTH-B initiative, which aims to provide comprehensive training ranging from basics to hands-on training on general aspects of operations and good manufacturing practices to aid the production of quality healthcare products. To this end, IVI will conduct the ‘Introductory Course for Standard Practice (GxP Course)’ in October as the second in the series. This three-week course will provide some 300 trainees from LMICs and Korea with professional training on international standards of quality for vaccine and biomedical product development and manufacturing known as ’Good Clinical, Manufacturing and Laboratory Practice (GCP, GMP, GLP – together GxP)’ and the basics of biosafety. The trainees will include technicians, engineers, scientists, and managers in biomanufacturing, and others working in the field with related experience. “The GxP course will bridge education of basic knowledge that has started this year and hands-on training onsite, which will be provided in earnest from next year,” said Ms. Alice Lee, coordinator of the two courses conducted by IVI. ### About the International Vaccine InstituteThe International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). Headquartered in Seoul, South Korea, IVI was the first international organization hosted by Korea. IVI has 39 countries and the World Health Organization (WHO) on its treaty, including Korea, Sweden, India, and Finland as state funders. Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A Strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int