The Global Vax Vaccine Manufacturing Workshop, hosted by USP’s Promoting the Quality of Medicines Plus (PQM+) program with support from USAID in Cape Town, brought together delegates from more than 21 countries and 18 different organizations to build manufacturing and regulatory competencies in Africa.

The 4-day workshop featured panel discussions and 55+ presentations covering the practical aspects of vaccine development, manufacturing complexities, regulatory dossier compilation, stakeholder engagement, and more, in addition to site visits to South African vaccine manufacturing facilities. In collaboration with AUDA-NEPAD, the South African Health Products Regulatory Authority, and Afrigen Biologics and Vaccines, USP invited speakers from stakeholder organizations including IVI as well as the South African Medical Research Council and Medicines Patent Pool in pursuit of the African Union’s goal to locally produce 60% of the vaccines needed on the continent by 2040.

On Day 1 of the workshop, IVI’s Director General Dr. Jerome Kim joined a panel discussion with the theme: Complexities and cost of vaccine manufacture on the continent—sustainability, policies, and recommendations, regional or pan-African. Dr. Kim highlighted the importance of training a skilled biomanufacturing workforce through programs such as the Global Training Hub for Biomanufacturing, transferring technology and know-how through public-private partnerships such as IVI’s partnership with Biovac in South Africa to enable production of oral cholera vaccine, and empowering global leadership for pandemic preparedness.

Additionally, Dr. Tarun Saluja, Head of Clinical Development at IVI, presented “From first-in-human study to licensure and beyond,” providing a detailed overview of every step of a clinical development plan using IVI’s Vi-DT typhoid conjugate vaccine as a case study.

On Day 3, Tobin Guarnacci, Global Head of Quality at IVI, presented an introduction to GxP quality management systems, including Good Manufacturing Practice, Good Clinical Practice, and Good Laboratory Practice (together, GxP). Total quality management includes the design of efficient monitoring tools and procedures for data collection and processing, as well as the collection of information that is essential to decision-making, which ensures GxP reporting is accurate, reliable, and timely.

Lastly, Dr. Ruchir Pansuriya, a research scientist in IVI’s Vaccine Process Development department, presented “Aseptic Processing: Behaviors, Processes, and Controls,” covering the key differences between the production of sterile drug products using aseptic processing vs. terminal sterilization.

The workshop agenda and all of the presentations are available here until March 17, 2023.