ArticleBiotechnology progress2022
Analysis of fouling and breakthrough of process related impurities during depth filtration using confocal microscopy.
Article in Biotechnology progress, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 16 citations in OpenAlex.
- Advances in Downstream Processing of Monoclonal Antibodies.Antibodies (Basel, Switzerland) · 2026Review
- Multiple Use of Regenerated Depth Filters in Antibody Purification Processes.Biotechnology and bioengineering · 2025Article
- Membrane Filtration of Nanoscale Biomaterials: Model System and Membrane Performance Evaluation for AAV2 Viral Vector Clarification and Recovery.Nanomaterials (Basel, Switzerland) · 2025Article
- Role of harvest depth filtration in controlling product-related impurities for a bispecific antibody.Antibody therapeutics · 2022Article
- Analysis of fouling and breakthrough of process related impurities during depth filtration using confocal microscopy.Biotechnology progress · 2022Article
- Automation of an integrated micro-scale platform for monoclonal antibody process development by incorporation of a depth filter mimic.Biotechnology progressArticle
- Optimizing clarification processes in biopharmaceutical manufacturing through quality by design: Strategies, implications, and future prospects.Biotechnology progressReview
- Use of LC-MS to characterize host cell protein removal during depth filtration.Biotechnology progressArticle
- Depth filter material process interaction in the harvest of mammalian cells.Biotechnology progressArticle
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
Titer improvement has driven process intensification in mAb manufacture. However, this has come with the drawback of high cell densities and associated process related impurities such as cell debris, host cell protein (HCP), and DNA. This affects the capacity of depth filters and can lead to carryover of impurities to protein A chromatography leading to early resin fouling. New depth filter materials provide the opportunity to remove more process related impurities at this early stage in the process. Hence, there is a need to understand the mechanism of impurity removal within these filters. In this work, the secondary depth filter Millistak+ X0HC (cellulose and diatomaceous earth) is compared with the X0SP (synthetic), by examining the breakthrough of DNA and HCP. Additionally, a novel method was developed to image the location of key impurities within the depth filter structure under a confocal microscope. Flux, tested at 75, 100, and 250 LMH was found to affect the maximal throughput based on the max pressure of 30 psi, but no significant changes were seen in the HCP and DNA breakthrough. However, a drop in cell culture viability, from 87% to 37%, lead to the DNA breakthrough at 10% decreasing from 81 to 55 L/m
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Registered trials
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