2011
DOI: 10.1002/elps.201000641
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Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

Abstract: An overview is given on the application of proteomic technology in the monitoring of different steps during the production of therapeutic proteins from human plasma. Recent advances in this technology enable the use of proteomics as an advantageous tool for the validation of already existing processes, the development and fine tuning of new production steps, the characterization and quality control of final products, the detection of both harmful impurities and modifications of the therapeutic protein and the … Show more

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Cited by 13 publications
(5 citation statements)
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References 153 publications
(238 reference statements)
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“…Neither HIC nor displacement chromatography have been routinely applied to the separation of proteins from human plasma. Elution‐modified displacement chromatography as an effective method for reversed‐phase separation of tryptic peptides as sample preparation for ESI MS was developed almost 10 years ago [], but this method did not find widespread acceptance. Ahrends et al [] recently compared displacement chromatography and gradient elution chromatography as the cation‐exchange step for sample preparation for ESI‐MS/MS.…”
Section: Discussionmentioning
confidence: 99%
“…Neither HIC nor displacement chromatography have been routinely applied to the separation of proteins from human plasma. Elution‐modified displacement chromatography as an effective method for reversed‐phase separation of tryptic peptides as sample preparation for ESI MS was developed almost 10 years ago [], but this method did not find widespread acceptance. Ahrends et al [] recently compared displacement chromatography and gradient elution chromatography as the cation‐exchange step for sample preparation for ESI‐MS/MS.…”
Section: Discussionmentioning
confidence: 99%
“…protein-protein interaction, PTMs or by simple binding of small ligands, and these molecules can be also a potential drug target. The role of proteomics, especially of plasma membrane proteomics can be: (i) identification of new drug targets, (ii) investigation of the mechanism of actions of the existing ones, (iii) elucidation of the development of drug resistance and (iv) early detection of possible harmful side effects such as immunological reaction of protein drugs [149] or rejection in organ transplantation [79].…”
Section: Plasma Membrane Proteins As Possible Molecular Targets For Amentioning
confidence: 99%
“…Cibachrom-blue is frequently used as an alternative to mAb for albumin removal from human plasma [57]. Immobilized heparin is frequently applied in plasma fractionation and for isolation of recombinant therapeutic proteins [34, 35, 37, 63], and SDC in affinity mode, as presented by Manseth et al [50], can be a valuable alternative for further optimization.…”
Section: Applications Of Sample Displacement Chromatographymentioning
confidence: 99%
“…Despite its importance as a starting material for diagnostic purposes and for discovery of new biomarkers, human plasma is still used as a valuable source for the isolation of therapeutic proteins [34, 35]. Large amounts of intravenous immunoglobulin (IVIG) and human serum albumin preparations originate from human plasma, and thousands of units of clotting factors and inhibitors are still needed in medicine as indispensable therapeutic agents [3537].…”
Section: Introductionmentioning
confidence: 99%
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