GMP Principles in Vaccine Manufacturing

In this two-day training, the history of vaccines and adverse events will be discussed, information will be presented about various vaccine types and production platforms, raw material, production, quality control, quality assurance, storage, and distribution processes in a GMP-compliant vaccine facility will be explained to the participants with examples and real-time scenarios.

With the advent of vaccine development, life expectancy has increased and the quality of life has improved visibly. Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. Some vaccines used today were developed in the 1940s and 1950s and have remained virtually unchanged. This situation is not surprising for experts who can read the pharmaceutical industry and the ecosystem dynamics that develop around it well. Just like small molecule chemical drugs, to maximise the life cycle of a vaccine, the most important prerequisite is that the raw materials, components, and consumables are in the same composition and consistency from the beginning.

The SARS-CoV-2 pandemic highlighted the importance of vaccines to control the consequences of COVID-19. Most of these GMP facilities are in the EU, USA, China, and European countries. To facilitate the access of these types of products to the rest of the world, the expansion of production capacities and installation of new GMP production plants is essential.

To optimise vaccine production processes and develop efficient and effective processes, it is necessary to continuously supply quality raw materials from reliable suppliers that have been audited and approved by internationally recognised, certified, competent, and experienced GMP auditors.

Compliance with cGMP requires setting up a quality system (QS), which will vary in complexity according to the size of the company. However, there are some basic principles to be followed in terms of design, manufacture, validation, quality control, packaging, labelling, and storage. As it is known, the use of living organisms in the vaccine manufacturing process brings safety requirements to the fore. This situation points to a more complex structure outside of traditional drug production.

One of the most obvious risks in vaccine production is undoubtedly cross-contamination. In such a risky environment, the importance of ensuring the cleanliness and safety of the area, equipment, and personnel and cleaning and disinfection increases. GMP compliance and safety requirements brought about by the use of negative and positive pressure rooms are some of the challenges of vaccine production. Although innovative approaches such as mRNA technology seem to minimise some risks, there is still a lot to be done.

This course will provide an excellent opportunity to become fully briefed on the GMP principles in vaccine manufacture and enable participants to discuss the techniques with an expert in this field.