Non-traditional antibacterial therapeutic: Focus on safety, manufacturing, and regulatory dynamics

Abstract

The escalating global menace posed by drug-resistant bacterial infections has fueled a surge in dedicated research aimed at uncovering revolutionary treatments. This chapter conducts a thorough examination of non-traditional approaches designed to navigate the complexities of bacterial drug resistance. Exploring a spectrum of strategies, the chapter investigates the regulatory landscape, manufacturing intricacies, and safety advancements associated with these innovative interventions. The array of non-traditional approaches discussed encompasses targeting virulence mechanisms, such as toxin production and virulence factor secretion, alongside inhibiting bacterial adhesion, biofilm formation, and disrupting communication pathways. Furthermore, the chapter delves into immune evasion, microbiome-modifying therapies, and the utilization of bacteriophages, both as treatments and carriers. Additional exploration is provided on the potential of nanoparticles, immunotherapy, antisense RNA, and drug-resistance- modulation approaches. Despite the promising potential offered by these non-antibiotic therapies, their development faces a multitude of obstacles and regulatory challenges. This chapter critically analyzes these hurdles, encompassing safety considerations, manufacturing complexities, and regulatory frameworks, shedding light on the collaborative endeavors among researchers, clinicians, and regulatory bodies. Through a comprehensive discussion, the chapter underscores the shared commitment to surmounting these challenges and propelling non-traditional approaches forward as viable solutions to counteract the escalating threat of drug-resistant bacterial infections. © The Author(s). All rights reserved.