Description
Title: Virus Filtration: Process- and Product-Related Foulants
Abstract: In order to ensure that contaminants are eliminated during the production of biopharmaceutical products, regulatory authorities have strict guidelines. The production process, not the molecular homogeneity, is used to validate heterogeneous molecules like monoclonal antibodies, Fc-fusion proteins, and other biotherapeutics derived from mammalian cells. A significant challenge in the downstream purification of these therapeutics is validating the clearance of potential viral contamination. Virus Filtration is a one-time, size-based separation technique in which the therapeutic molecules pass through the membrane pores while the contaminating virus particles are retained. The general virus clearance strategy frequently includes virus filtration. virus’s compromised performance filters due to membrane fouling, low throughput, and reduced viral clearance, is of great industrial significance and frequently poses a significant difficulty. This review demonstrates how product variations, contaminants, and byproducts from cell culture can affect the virus filtration of biologics made from mammalian cells. Host cell proteins, proteases, and endotoxins are among the foulants produced by cell culture. Additionally, we offer prevention strategies for each potential foulant.
Keywords: aggregation; charge variant; downstream processing; fusion protein; foulant; glycoform; prefiltration; process development; monoclonal antibody; virus filtration
Paper Quality: SCOPUS / Web of Science Level Research Paper
Subject: Bioengineering
Writer Experience: 20+ Years
Plagiarism Report: Turnitin Plagiarism Report will be less than 10%
Restriction: Only one author may purchase a single paper. The paper will then indicate that it is out of stock.
What will I get after the purchase?
A turnitin plagiarism report of less than 10% in a pdf file and a full research paper in a word document.
In case you have any questions related to this research paper, please feel free to call/ WhatsApp on +919726999915
Reviews
There are no reviews yet.