Evaluation of on-line high-performance size-exclusion chromatography, differential refractometry, and multi-angle laser light scattering analysis for the monitoring of the oligomeric state of human immunodeficiency virus vaccine protein antigen

Barackman, J. D.; Prado, Isaias; Karunatilake, Chulani; Furuya, Kenji

doi:10.1016/j.chroma.2004.02.011

Cited by 16 publications

(12 citation statements)

References 26 publications

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“…This approach works well for bind and elute applications, when the whole peak is to be collected from baseline to baseline and the protein concentration is linearly correlated to the absorbance signal for the range under consideration. The accuracy of the approach was found to be >89% and the intra-and interday precision were found to be 0.9 and 3.6% RSD, respectively (Barackman et al, 2004). Thus, since impurity levels in the feed material vary from lot to lot, pool purity also varies.…”

Section: Introductionmentioning

confidence: 93%

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Rathore

Yeboah

et al. 2007

Biotech & Bioengineering

112

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Process analytical technology (PAT) has been gaining a lot of momentum in the biopharmaceutical community due to the potential for continuous real time quality assurance resulting in improved operational control and compliance. This paper presents a PAT application for one of the most commonly used unit operation in bioprocessing, namely liquid chromatography. Feasibility of using a commercially available online-high performance liquid chromatography (HPLC) system for real-time pooling of process chromatography column is examined. Further, experimental data from the feasibility studies are modeled and predictions of the model are compared to actual experimental data. It is found that indeed for the application under consideration, the online-HPLC offers a feasible approach for analysis that can facilitate real-time decisions for column pooling based on product quality attributes. It is shown that implementing this analytical scheme allows us to meet two of the key goals that have been outlined for PAT, that is, "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." Finally, the implications of implementing such a PAT application in a manufacturing environment are discussed. The application presented here can be extended to other modes of process chromatography and/or HPLC analysis.

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Section: Introductionmentioning

confidence: 93%

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Rathore

Yeboah

et al. 2007

Biotech & Bioengineering

112

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“…In particular, high performance liquid chromatography (HPLC) and ultra performance liquid chromatography (UPLC) based methods have been implemented in downstream purification processes to provide real‐time concentration or purity measurements. These data have been used to inform chromatography pooling decisions, control chromatography loading factors, and ensure consistency of tertiary structure in oligomeric protein preparations . We postulated that a UPLC based PAT method would also be suitable for real‐time monitoring of MF performance.…”

Section: Introductionmentioning

confidence: 99%

At-line process analytical technology (PAT) for more efficient scale up of biopharmaceutical microfiltration unit operations

Watson

Kerchner

Gant

et al. 2015

Biotechnol Progress

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Tangential flow microfiltration (MF) is a cost-effective and robust bioprocess separation technique, but successful full scale implementation is hindered by the empirical, trial-and-error nature of scale-up. We present an integrated approach leveraging at-line process analytical technology (PAT) and mass balance based modeling to de-risk MF scale-up. Chromatography-based PAT was employed to improve the consistency of an MF step that had been a bottleneck in the process used to manufacture a therapeutic protein. A 10-min reverse phase ultra high performance liquid chromatography (RP-UPLC) assay was developed to provide at-line monitoring of protein concentration. The method was successfully validated and method performance was comparable to previously validated methods. The PAT tool revealed areas of divergence from a mass balance-based model, highlighting specific opportunities for process improvement. Adjustment of appropriate process controls led to improved operability and significantly increased yield, providing a successful example of PAT deployment in the downstream purification of a therapeutic protein. The general approach presented here should be broadly applicable to reduce risk during scale-up of filtration processes and should be suitable for feed-forward and feed-back process control.

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“…Furthermore, the combination of HPSEC and multi-angle laser light scattering (MALLS) makes it possible to analyze size distributions of highly polydisperse samples and to obtain both differential and cumulative distributions of the molecular weight and the mean square radius. It has been widely applied for the determination of protein molecular weights, molecular size and their distributions [19][20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

Molecular characterization of recombinant Hepatitis B surface antigen from Chinese hamster ovary and Hansenula polymorpha cells by high-performance size exclusion chromatography and multi-angle laser light scattering

Zhou

Janson

et al. 2006

Journal of Chromatography B

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Evaluation of on-line high-performance size-exclusion chromatography, differential refractometry, and multi-angle laser light scattering analysis for the monitoring of the oligomeric state of human immunodeficiency virus vaccine protein antigen

Cited by 16 publications

References 26 publications

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

At-line process analytical technology (PAT) for more efficient scale up of biopharmaceutical microfiltration unit operations

Molecular characterization of recombinant Hepatitis B surface antigen from Chinese hamster ovary and Hansenula polymorpha cells by high-performance size exclusion chromatography and multi-angle laser light scattering

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