A validated capillary electrophoresis method to check for batch-to-batch consistency during recombinant human glycosylated interleukin-7 production campaigns

Alahmad, Youssef; Taverna, Myriam; Mobdi, Hanane; Duboeuf, Jérémy; Grégoire, Anne; Rancé, Iann; Tran, Nguyet Thuy

doi:10.1016/j.jpba.2009.09.013

Cited by 10 publications

(1 citation statement)

References 20 publications

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“…A precise and robust CZE method was successfully applied to distinguish between rhIL‐7 samples produced using prokaryotic and eukaryotic cell lines; to compare the glycosylation pattern of two rhIL‐7 samples produced by CHO cell lines and purified using the slightly different purification processes; and to assess batch to batch consistency of rhIL‐7 products with regard to glycosylation complexity. Dynamically coated capillaries with diaminobutane have been used to achieve the best separation among glycoforms .…”

Section: Ce‐based Methods Applied In the Quality Control Of Biopharmamentioning

confidence: 99%

The potential of the capillary electrophoresis techniques for quality control of biopharmaceuticals—A review

Tamizi

Jouyban

2015

Electrophoresis

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CE is considered as a powerful technique in biopharmaceutical industry, owing to its inherent advantages such as high resolution, efficient separation, and its flexibility to couple with high-sensitive detecting methods. Present review provides a summary of the applications of CE-based methods in the quality control of biopharmaceuticals according to the papers published between 1994 and July 2014. This article is divided into the sections based on different CE modes applied in the analysis of biopharmaceuticals and gives detailed information about the employed experimental conditions. At the end some overall conclusions and perspectives are given.

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Section: Ce‐based Methods Applied In the Quality Control Of Biopharmamentioning

confidence: 99%

The potential of the capillary electrophoresis techniques for quality control of biopharmaceuticals—A review

Tamizi

Jouyban

2015

Electrophoresis

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Current Awareness in Drug Testing and Analysis

2010

Drug Testing and Analysis

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J Forensic Sci 2010 55 (2) 451 Paradigm shift for the alcohol breath testThe alcohol breath test (ABT) has been used for quantification of ethyl alcohol in individuals suspected of driving under the influence for more than 50 years. In this time, there has been little change in the concepts underlying this single breath test. The old model, which assumes that end-exhaled breath alcohol concentration is closely related to alveolar air alcohol concentration, is no longer acceptable. This paper reviews experimental research and mathematical modeling which has evaluated the pulmonary exchange processes for ethyl alcohol. Studies have shown that alcohol exchanges dynamically with the airway tissue both during inspiration and expiration. The airway tissue interaction makes it impossible to deliver air with alveolar alcohol concentration to the mouth. It is concluded that the ABT is dependent on physiological factors that need to be assessed for accurate testing Jackson G, Arver S, Banks I, Stecher VJ// London Bridge Hosp, 27 Tooley St, Emblem House, London SE1 2PR, England Int J Clin Pract 2010 64 (4) 497 Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks Counterfeit drugs are inherently dangerous and a growing problem; counterfeiters are becoming increasingly sophisticated. Growth of the counterfeit medication market is attributable in part to phosphodiesterase type 5 inhibitor (PDE5i) medications for erectile dysfunction (ED). Millions of counterfeit PDE5is are seized yearly and account for the bulk of all counterfeit pharmaceutical product seizures. It has been estimated that up to 2.5 million men in Europe are exposed to illicit sildenafil, suggesting that there may be as many illegal as legal users of sildenafil. Analysis of the contents of counterfeit PDE5is shows inconsistent doses of active pharmaceutical ingredients (from 0% to > 200% of labelled dose), contaminants (including talcum powder, commercial paint and printer ink) and alternative ingredients that are potentially hazardous. In one analysis, only 10.1% of samples were within 10% of the labelled tablet strength. Estimates place the proportion of counterfeit medications sold over the Internet from 44% to 90%. Of men who purchase prescription-only medication for ED without a prescription, 67% do so using the Internet. Counterfeit PDE5is pose direct and indirect risks to health, including circumvention of the healthcare system. More than 30% of men reported no healthcare interaction when purchasing ED medications. Because > 65% actually had ED, these men missed an opportunity for evaluation of comorbidities (e.g. diabetes and hypertension). Globally, increased obstacles for counterfeiters are necessary to combat pharmaceutical counterfeiting, including fines and penalties. The worldwide nature of the counterfeit problem requires proper coordination between countries to ensure adequate enforcement. Locally, physicians who treat ED need to inform patients of the dangers of ordering PDE5is via the Internet

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Applications of capillary electrophoresis in characterizing recombinant protein therapeutics

Zhao

Chen

2013

Electrophoresis

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The use of recombinant protein for therapeutic applications has increased significantly in the last three decades. The heterogeneity of these proteins, often caused by the complex biosynthesis pathways and the subsequent PTMs, poses a challenge for drug characterization to ensure its safety, quality, integrity, and efficacy. CE, with its simple instrumentation, superior separation efficiency, small sample consumption, and short analysis time, is a well-suited analytical tool for therapeutic protein characterization. Different separation modes, including CIEF, SDS-CGE, CZE, and CE-MS, provide complementary information of the proteins. The CE applications for recombinant therapeutic proteins from the year 2000 to June 2013 are reviewed and technical concerns are discussed in this article.

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A validated capillary electrophoresis method to check for batch-to-batch consistency during recombinant human glycosylated interleukin-7 production campaigns

Cited by 10 publications

References 20 publications

The potential of the capillary electrophoresis techniques for quality control of biopharmaceuticals—A review

The potential of the capillary electrophoresis techniques for quality control of biopharmaceuticals—A review

Current Awareness in Drug Testing and Analysis

Applications of capillary electrophoresis in characterizing recombinant protein therapeutics

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