RESUMO
In recent years, the development of novel recombinant virus-like particles (VLPs) has been generating new perspectives for the prevention of untreated and arising infectious diseases. However, cost-reduction and acceleration of manufacturing processes for VLP-based vaccines or vectors are key challenges for the global health system. In particular, the design of rapid and cost-efficient purification processes is a critical bottleneck. In this review, we describe and evaluate new concepts, development strategies and unit operations for the downstream processing of VLPs. A special focus is placed on purity requirements and current trends, as well as chances and limitations of novel technologies. The discussed methods and case studies demonstrate the advances and remaining challenges in both rational process development and purification tools for large biomolecules. The potential of a new era of VLP-based products is highlighted by the progress of various VLPs in clinical phases.
Assuntos
Proteínas Recombinantes/isolamento & purificação , Tecnologia Farmacêutica/métodos , Vacinas de Partículas Semelhantes a Vírus/isolamento & purificação , Vetores Genéticos , Humanos , Proteínas Recombinantes/imunologia , Tecnologia Farmacêutica/tendências , Vacinas de Partículas Semelhantes a Vírus/biossíntese , Vacinas de Partículas Semelhantes a Vírus/economiaRESUMO
Session 10 of the Virus-like Particle and Nano-Particle Vaccines meeting 2014 focused on new methods in vaccine technology to accelerate process development, manufacturing and quality control. The session presented new ways of quantifying and characterizing particle samples. In addition platform approaches for production and purification of virus-like particle (VLP) vaccines were highlighted.