Contemporary issues involving biologic medicines and vaccines: formulation stability, protein aggregation, and vaccine hesitancy

Abstract

The advancement of biologic medicines such as protein-based therapeutics and vaccines has played important roles in protecting as well as promoting human health. Significant progress has been made in understanding the immune system and the mechanisms underlying diseases, which aid the development of biologics for various diseases. The development of protein-based therapeutics has transformed the treatment of numerous illnesses, including cancer, autoimmune and viral infections, cardiovascular disease, as well as organ transplant rejection prevention. Vaccination has become one of the most major public health achievements, playing crucial role in smallpox eradication and control several infectious diseases such as rubella, diphtheria, and polio worldwide. Nevertheless, numerous challenges and obstacles remain in the healthcare sector. Maintaining the integrity of a protein-based therapeutics to develop a stable and high formulation presents substantial hurdles due to the complexity and fragility of proteins. Although the prevalence and fatality rates of infectious diseases have decreased, several of them continue to pose significant risk due to their pandemic potential. Vaccination, despite its widely acknowledge effectiveness as a key public health measure, is nonetheless seen as harmful and unnecessary by a growing number of people for a variety of reasons. This delay in vaccine acceptance as well as refusal has become a severe threat to vaccination programme. This thesis addresses the contemporary issues and challenges associated with biologic medicines, as well as potential approaches and strategies for mitigating these obstacles.