Viral Filtration: A Review of Current and Future Practices in Bioprocessing

Abstract

For drug products manufactured in mammalian cells, safety assurance practices are needed during production to assure that the final medicinal product is safe from the potential risk of viral contamination. Virus filters provide viral retention for a range of viruses through robust, size-based retention mechanism. Therefore, a viral filtration step is commonly utilized in a well-designed recombinant therapeutic protein purification process and is a key component in an overall strategy to minimize the risks of adventitious and endogenous viral particles during the manufacturing of biotechnology products. This review summarizes the history of viral filtration, currently available viral filters and prefilters, and viral filtration integrity test methods and study models. There is also discussion of current understanding and gaps with an eye toward future trends and emerging filtration technologies.

Fouling of virus filtration membranes by monoclonal antibody feeds with low aggregate content

“…In this manuscript, we focus on one of the last steps in the production of mAbs for medical treatment, in which polymeric membranes are used to filter viruses from the mAb solution by size exclusion, as required by FDA regulations (Brorson et al, 2022; FDA, 2022; Johnson et al, 2021). One of the challenges of this filtration process is mAb fouling.…”