IVI successfully completes the '2022 Introductory Course for Biologics Development and Manufacturing'

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."

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."

Dr. Rohaida Hashim, senior researcher, National Institute of Health, Ministry of Health of Malaysia

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.