Isolator and RAB systems in aseptic processing: Applications in advanced therapies, vaccine development and environmental microbiology
1 Department of Health and Medical Sciences, Santa Úrsula University, Fernando Ferrari, 75 – Botafogo, Rio de Janeiro, Brazil.
2 PhD Tropical Medicine, Oswaldo Cruz Foundation, Avenida Brazil 4.365 – Manguinhos, Rio de Janeiro, Brazil.]
Review
International Journal of Science and Technology Research Archive, 2026, 10(01), 051-057.
Article DOI: 10.53771/ijstra.2026.10.1.0013
Publication history:
Received on 19 January 2026; revised on 26 February 2026; accepted on 28 February 2026
Abstract:
In aseptic processing, restricted access barrier systems (RABs) feature translucent rigid barriers that confine and separate the aseptic operating area from the surrounding cleanroom environment in a Grade A environment. Similarly, isolators are essential in gene therapy production, creating hermetically sealed and sterile environments with HEPA filters to protect products from microbiological contamination. In this sense, isolators are crucial for the manipulation of cells and viral vectors, enabling the aseptic production of advanced therapies such as those based on chimeric antigen receptor-associated T cells (CAR) ex vivo gene therapy and viral vectors in vivo gene therapy. For both isolators and RABs, the materials used in glove systems must be defined through strategic contamination control. Thus, isolators and RABs act as a bridge between research and clinical application, being fundamental for the manipulation of vectors with genetically modified viruses that deliver therapeutic genes to target cells, ensuring quality through good manufacturing practices and proving the efficacy of the most advanced treatments. These gene therapy processes require the use of isolators to guarantee an aseptic process with microbiological decontamination, being considered ideal for small-scale production with smaller and customized batches of advanced therapies. In short, isolators and RABs are the backbone of the safe and efficient production of gene therapies, ensuring that transformative innovations reach patients without risks and free of contaminants.
Keywords:
Chimeric Antigen Receptor T Cells; Isolators; Aseptic Process; Gene Therapy; Viral Vectors
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Copyright © 2026 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0