A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis: Additional Instruments/Buffer

Nunnally, Brian K.; Park, Sungae; Patel, Ketaki; Hong, Mingfang; Zhang, Xinfeng; Wang, Shaoxiong; Rener, Brenda; Reed-Bogan, Angelia; Salas‐Solano, Oscar; Lau, Wendy; Girard, Michel; García‐Cañas, Virginia; Cheng, Kuang-Chuan; Zeng, Mingyong; Ruesch, Margaret N.; Frazier, Ronald B.; Jochheim, Claudia M.; Natarajan, K. A.; Jessop, K. Michael; Saeed, Mansoor; Moffatt, Frank; Madren, Seth; Thiam, Serigne; Altria, Kevin D.

doi:10.1365/s10337-007-0437-x

Cited by 15 publications

(18 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The absolute t m repeatability for laboratories 1–11 was around 0.7% RSD (Supporting Information Table 1) and hence better than results obtained on bare fused‐silica capillaries, presumably due to the use of the PVA coating. In terms of t m ′ repeatability and reproducibility, similar results were reported by an intercompany study for protein analysis by CGE with UV detection . In contrast to t m ′ (Fig.…”

Section: Resultssupporting

confidence: 87%

“…In contrast to t m ′ (Fig. A) , only little dependence of t m repeatability or reproducibility on t m was observed in the present work and the cited studies (Supporting Information Table 1) . These observations imply that the t m ′ precision could be further improved by employing multiple internal standards.…”

Section: Resultscontrasting

confidence: 58%

“…1D). However, the observed %A reproducibility was less good compared to inter‐laboratory studies employing CGE or CIEF with UV detection for protein analysis that reported values below 9% RSD . In contrast to spectrophotometric detection, in ESI‐MS the response is depending on many factors like ion formation, ion capture and introduction and magnetic and/or electric field focusing.…”

Section: Resultsmentioning

confidence: 79%

“…CE has become increasingly used for the characterization of biopharmaceuticals and has shown very good intermediate precision. Previously, several CE methods employing UV‐vis spectrophotometric or LIF detection were investigated for robustness and precision among multiple sites . Some of them were incorporated into pharmacopoeial monographs, especially in case of proteins and peptides .…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Interlaboratory study to evaluate the robustness of capillary electrophoresis‐mass spectrometry for peptide mapping

Wenz

Barbas

López‐Gonzálvez

et al. 2015

J of Separation Science

View full text Add to dashboard Cite

A collaborative study on the robustness and portability of a capillary electrophoresis-mass spectrometry method for peptide mapping was performed by an international team, consisting of 13 independent laboratories from academia and industry. All participants used the same batch of samples, reagents and coated capillaries to run their assays, whereas they utilized the capillary electrophoresis-mass spectrometry equipment available in their laboratories. The equipment used varied in model, type and instrument manufacturer. Furthermore, different types of sheath-flow capillary electrophoresis-mass spectrometry interfaces were used. Migration time, peak height and peak area of ten representative target peptides of trypsin-digested bovine serum albumin were determined by every laboratory on two consecutive days. The data were critically evaluated to identify outliers and final values for means, repeatability (precision within a laboratory) and reproducibility (precision between laboratories) were established. For relative migration time the repeatability was between 0.05 and 0.18% RSD and the reproducibility between 0.14 and 1.3% RSD. For relative peak area repeatability and reproducibility values obtained were 3-12 and 9-29% RSD, respectively. These results demonstrate that capillary electrophoresis-mass spectrometry is robust enough to allow a method transfer across multiple laboratories and should promote a more widespread use of peptide mapping and other capillary electrophoresis-mass spectrometry applications in biopharmaceutical analysis and related fields.

show abstract

Section: Resultssupporting

confidence: 87%

Section: Resultscontrasting

confidence: 58%

Section: Resultsmentioning

confidence: 79%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Interlaboratory study to evaluate the robustness of capillary electrophoresis‐mass spectrometry for peptide mapping

Wenz

Barbas

López‐Gonzálvez

et al. 2015

J of Separation Science

View full text Add to dashboard Cite

show abstract

“…Reliability of CE instruments must be examined since in the past instrument‐dependent problems in routine analysis (particularly in CE‐SDS) were frequently reported . Therefore, the reliability of capillary electrophoresis methods including the instrumentation used was investigated by a CASSS subsection and published online .…”

Section: Introductionmentioning

confidence: 99%

The next generation of capillary electrophoresis instruments: Performance of CE‐SDS protein analysis

2017

View full text Add to dashboard Cite

Over the last decade, capillary electrophoresis gained tremendous importance, because it became an indispensible tool for the quality control of biologics, e.g. therapeutic antibodies. Consequently, there has been a continuous development within the CE market. Microchip techniques have been established in the last years. Further trends are complete solutions for specific applications by the usage of reagent kits. Step by step instructions and facilitated handling of the instruments are becoming more common. This work focuses on the sized-based protein analysis with CE-SDS. The instruments CE 7100 by Agilent Technologies, LabChip® GXII Touch HT by PerkinElmer, Maurice S. by Protein Simple and PrinCE NextI870 by Prince Technologies have been evaluated, mainly analyzing protein mixtures of different molecular weights in long series. Published data of the PA 800 plus by SCIEX are also included in the tabled results. Precision, reliability, flexibility, and speed have been identified as the most important performance parameters, others such as resolution, sensitivity, linearity, ease of use and sustainability have also been considered. All tested instruments have shown an excellent performance. Depending on application and necessities, each user can find the most appropriate one.

show abstract

Fluctuations in dissolved oxygen concentration during a CHO cell culture process affects monoclonal antibody productivity and the sulfhydryl‐drug conjugation process

Hippach¹,

Schwartz²,

Pei³

et al. 2018

Biotechnology Progress

View full text Add to dashboard Cite

During a CHO cell culture production process, important parameters are generally well controlled by a feedback mechanism (PID loop) in order to ensure consistency in both productivity and product quality. These parameters typically include pH, dissolved oxygen (DO), and temperature. While most of these parameters are very well controlled within their specific deadband, stable DO control can be challenging. Oscillations in DO concentration are not uncommon and these fluctuations can be exacerbated with an efficient mass transfer aeration strategy. In this study, where an IgG producing cell line was used, we observed increased lactate accumulation accompanied by decreased titer production in lots with fluctuations in DO concentration (DO ) when compared with lots with stable DO control (DO ). We demonstrate that DO had a greater impact on performance with respect to titer production and lactate accumulation than DO setpoint. Furthermore, we report that estimated specific oxygen uptake rates (qOURs) were lower in DO lots when compared with DO lots. We also report that purified mAb sourced from DO lots yielded lower drug-to-antibody ratio (DAR) after the sulfhydryl-targeted maleimide conjugation process when equivalent reducing agent was used. All mAb lots were within the analytical specifications for release, though a slight increase in measureable trisulfides were observed in DO mAb lots. DO control aimed to minimize fluctuations around DO setpoint was essential for us to produce consistent DAR without adjusting the conjugation process. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 2018.

show abstract

A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis: Additional Instruments/Buffer

Cited by 15 publications

References 2 publications

Interlaboratory study to evaluate the robustness of capillary electrophoresis‐mass spectrometry for peptide mapping

Interlaboratory study to evaluate the robustness of capillary electrophoresis‐mass spectrometry for peptide mapping

The next generation of capillary electrophoresis instruments: Performance of CE‐SDS protein analysis

Fluctuations in dissolved oxygen concentration during a CHO cell culture process affects monoclonal antibody productivity and the sulfhydryl‐drug conjugation process

Contact Info

Product

Resources

About