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primary topic: Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins

Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins
type: Article
abstract: Antibodies are an integral part of the human immune system. They are mostly Y-shaped monomeric molecules with different roles in the destruction of specifically targeted cells or molecules. Therefore, their specific targeting and binding ability has been explored by researchers and pharmaceutical industry for their application as drug substance. Ever since 1975, when the first hybridoma technology was invented by Köhler and Milstein, to produce pure mouse antibody, technologies involving anti-body production has increased significantly. Today, mostly IgG monoclonal antibodies with their subtypes are used as drug sub-stance and their production is done through genetically engineered CHO cells in a cell culture, followed by a multi-step purification train. As part of this purification platform, cation exchange is often used to mildly separate aggregates and other product- and process-related impurities, that could potentially elicit an immune response from the patient. However, in the recent years, more and more publications showed a phenom-enon during cation exchange chromatography, the two-peak elution behavior. In most-ly a salt gradient elution, and sometimes after a certain hold time on the column, the protein elutes in two distinct peaks, instead of just one, as expected. These publica-tions also show that this phenomenon is mostly protein-dependent and has several different explanations. In my project, I used a standard approach to elicit this two-peak elution behavior with a monoclonal antibody held on a cation exchange resin for 1000 min before elution in a salt gradient to 1 M NaCl. To elucidate what exactly the second peak is, I used size exclusion chromatography. It was found that the second peak is mostly comprised of monomer, which are probably conformationally altered, but also ~30% aggregates, which are reversible, depending on the buffer pH value. I further investigated several influential factors on this phenomenon. Bead size, tenta-cle technology, b…
date: 2023
author list: authors
type: EPrint
type: DoctoralThesisEPrint
is part of: repository
has document: Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (PDF)
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Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (PDF)
type: Document
has file: Dissertation_Carolin Stange.pdf
has part: Dissertation_Carolin Stange.pdf

Carolin Stange
type: Person
given name: Carolin
family name: Stange

Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (Other)
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Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (Other)
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Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (Other)
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Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (Other)
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Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins (Other)
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primary topic: Characterization of excipients for their application during purification of monoclonal antibodies and other therapeutic proteins