Characterization of factor VIII pharmaceutical preparations by means of MudPIT proteomic approach

Basilico, Fabrizio; Nardini, Ilaria; Mori, Filippo; Brambilla, Eugenio; Benazzi, Louise; Palma, Antonella De; Rosti, Enrico; Farina, Claudio; Mauri, Pierluigi

doi:10.1016/j.jpba.2010.03.027

Cited by 9 publications

(8 citation statements)

References 34 publications

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“…Interestingly, in one of investigated concentrates no contaminating proteins could be detected by use of this method. In contrast, Basilico et al [107] identified 14 serum proteins in this concentrate by use of multidimensional protein identification technology. Over-expression of Hsps in different cell lines, such as Chinese hamster ovary cells, has been used as a tool in order to achieve extended cell viability and improved production of recombinant therapeutic proteins [55].…”

Section: Clotting Factor VIII and Vwfmentioning

confidence: 97%

“…These two proteins can cause F VIII activation during the production process and product storage [7]. Basilico et al [107] performed multidimensional protein identification technology experiments on a similar pd F VIII/VWF concentrate. Basically, similar bulk impurities were identified by both groups, but they reported detection of F II in only some of their investigated batches.…”

Section: Clotting Factor VIII and Vwfmentioning

confidence: 99%

“…Commercial rF VIII concentrates were investigated by Basilico et al [107] and D'Amici et al [11]. The second group used 2-D EF and ion trap MS in order to follow F VIII degradation by thrombin and for identification of impurities.…”

Section: Clotting Factor VIII and Vwfmentioning

confidence: 99%

“…f) Error factor. The multipicative factor to determine ratio range: The true ratio should fall within ratio/EF and ratio Ã EF Reprinted from Reference [107] with permission. Electrophoresis 2011, 32, 1104-1117 of F IX and the mechanisms of its interactions with many proteins and inhibitors have been widely explored [112,[115][116][117][118].…”

Section: Clotting Factor IXmentioning

confidence: 99%

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Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

et al. 2011

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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 auditing of batch-to-batch variations. Further, use of proteomics for preclinical testing of new products, which can be either recombinant or plasma-derived, is also discussed.

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Section: Clotting Factor VIII and Vwfmentioning

confidence: 97%

Section: Clotting Factor VIII and Vwfmentioning

confidence: 99%

Section: Clotting Factor VIII and Vwfmentioning

confidence: 99%

Section: Clotting Factor IXmentioning

confidence: 99%

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Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

et al. 2011

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“…The low abundance proteins are frequently potential biomarkers or biomarker candidates for various diseases [1]. After isolation and purification, some of biologically active proteins that are present in human plasma in very low concentrations such as clotting factors and inhibitors can be used for therapeutic purposes [5–7]. Both optimization industrial scale plasma fractionation and serum and plasma separation in order to isolate low abundance proteins in these complex biological fluids have alredy been topic of many studies [8, 9].…”

Section: Introductionmentioning

confidence: 99%

Selectivity of monolithic supports under overloading conditions and their use for separation of human plasma and isolation of low abundance proteins

Brgles¹,

Clifton²,

Walsh³

et al. 2011

Journal of Chromatography A

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Human serum albumin (HSA) and immunoglobulin G (IgG) represent over 75% of all proteins present in human plasma. These two proteins frequently interfere with detection, determination and purification of low abundance proteins that can be potential biomarkers and biomarker candidates for various diseases. Some low abundance plasma proteins such as clotting factors and inhibitors are also important therapeutic agents. In this paper, the characterization of ion-exchange monolithic supports under overloading conditions was performed by use of sample displacement chromatography (SDC). If these supports were used for separation of human plasma, the composition of bound and eluted proteins in both anion- and cation-exchange mode is dependent on column loading. Under overloading conditions, the weakly bound proteins such as HSA in anion-exchange and IgG in cation-exchange mode are displaced by stronger binding proteins, and this phenomenon was not dependent on column size. Consequently, small monolithic columns with a column volume of 100 and 200 μL are ideal supports for high-throughput screening in order to develop new methods for separation of complex mixtures, and for sample preparation in proteomic technology.

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Genomics and Proteomics of Pulmonary Vascular Disease

Geraci

Meyrick

2011

Comprehensive Physiology

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Study of RNA and proteins in cells of both normal and diseased tissues is providing researchers with new knowledge of disease pathologies. While still in its early stages, high-throughput expression analysis is improving our understanding of the pathogenesis of pulmonary arterial hypertension (PAH). While many studies have used microarray and proteomic analyses as "hypothesis-generating" tools, the technologies also have potential to identify and quantify biomarkers of disease. To date, many of the published studies have examined gene expression profiles of tissue biopsies, others have utilized cells from peripheral blood. Microarray technology has been employed successfully in the investigation of a diverse array of human diseases. The potential of high-throughput expression analysis to improve our understanding of the pathogenesis of PAH is highlighted in this review. Proteomic studies of PAH and pulmonary vascular diseases in general have been little utilized thus far. To date, such studies are few and no consistent biomarker has emerged from studies of either plasma or blood cells from idiopathic pulmonary arterial hypertension (IPAH) patients. The studies of both lung tissue and lymphocytes are perhaps more revealing and suggest that changes in the cytoskeletal machinery may play a role in the pathogenesis of idiopathic pulmonary arterial hypertension. The oncology literature has demonstrated the utility of gene microarray analysis to predict important outcomes such as response to therapy and survival. It is likely that in the near future, gene microarrays and proteomic analyses will also be employed in a pharmacogenomics approach in PAH, helping to identify the most appropriate therapies for individual patients.

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Characterization of factor VIII pharmaceutical preparations by means of MudPIT proteomic approach

Cited by 9 publications

References 34 publications

Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

Selectivity of monolithic supports under overloading conditions and their use for separation of human plasma and isolation of low abundance proteins

Genomics and Proteomics of Pulmonary Vascular Disease

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