Optimization Opportunities in a Regulated Environment

Kromidas, Stavros

doi:10.1002/9783527837489.ch1-9

Cited by 2 publications

(4 citation statements)

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“…For the separation of 7-20 analytes, the SOS-LC using an isocratic elution is a suitable approach. For more than 20 analytes, the SOS-LC should be supplemented with gradient elution as increased peak capacities are required [42].…”

Section: Discussionmentioning

confidence: 99%

“…In the previously presented applications, the information necessary for the optimization was based on the separation of one critical peak pair only, the peak pair with the lowest resolution. This peak pair may change during different iterations of the optimization process [42]. Thus, challenges arise by measuring complex matrices, that is, chromatographic fingerprints.…”

Section: Stationary Phase Optimized Selectivity Liquid Chromatographymentioning

confidence: 99%

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Selectivity optimization in liquid chromatography via stationary phase tuning

Jaekel,

Legelli,

Wirtz

et al. 2023

J of Separation Science

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In striving for the best possible separation, the selectivity of stationary phases as an optimization parameter is often underestimated although there are many ways to influence this powerful tool. This review serves to provide an insight into the various ways of adapting the selectivity of a separation in liquid chromatography. Approaches via temperature and flow rate tuning are discussed as a basis followed by focusing on the stationary phase as the superior optimization parameter. Highly selective stationary phases hereby provide an advantage for groups of similar analytes. For more complex mixtures, separations can be improved using mixed‐mode technologies where different retention mechanisms are combined. Serial coupling, mixed‐bed columns, and stationary phase optimized selectivity liquid chromatography provide solutions to various degrees. Finally, the advantages of stationary phase tuning over adaption of mobile phase and/or temperature are presented in terms of optimum application range.

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Section: Discussionmentioning

confidence: 99%

Section: Stationary Phase Optimized Selectivity Liquid Chromatographymentioning

confidence: 99%

Selectivity optimization in liquid chromatography via stationary phase tuning

Jaekel,

Legelli,

Wirtz

et al. 2023

J of Separation Science

View full text Add to dashboard Cite

show abstract

“…A "salt-free" SEC-MS method has also been proposed for aggregate analysis (Kromidas, 2021;Lazar et al, 2005;Liu et al, 2009). Trifluoroacetic acid (TFA) and/or FA used in the mobile phase caused the denaturation of protein biopharmaceuticals.…”

Section: Aggregate Analysismentioning

confidence: 99%

“…HILIC is easily compatible with MS, but it has denaturing method (Sandra et al, 2014). Moreover, the issues of irreversible protein adsorption on HILIC material and protein solubility may be encountered (Kromidas, 2021;Staub et al, 2011). Generic conditions in the HILIC method employ a wide-pore amide stationary phase, ACN-based TFA-containing mobile phase, and elevated temperature (Periat et al, 2015).…”

Section: Analysis Of Glycan Profilementioning

confidence: 99%

What is the role of current mass spectrometry in pharmaceutical analysis?

Khalikova

Jireš

Horáček

et al. 2023

Mass Spectrometry Reviews

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The role of mass spectrometry (MS) has become more important in most application domains in recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number of routine quality control analyses to be carried out. The role of MS is, therefore, very different throughout the whole drug development cycle. While it dominates within the drug discovery and development phase, in routine quality control, the role of MS is minor and indispensable only for selected applications. Moreover, its role is very different in the case of analysis of small molecule pharmaceuticals and biopharmaceuticals. Our review explains the role of current MS in the analysis of both small‐molecule chemical drugs and biopharmaceuticals. Important features of MS‐based technologies being implemented, method requirements, and related challenges are discussed. The differences in analytical procedures for small molecule pharmaceuticals and biopharmaceuticals are pointed out. While a single method or a small set of methods is usually sufficient for quality control in the case of small molecule pharmaceuticals and MS is often not indispensable, a large panel of methods including extensive use of MS must be used for quality control of biopharmaceuticals. Finally, expected development and future trends are outlined.

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Optimization Opportunities in a Regulated Environment

Cited by 2 publications

References 0 publications

Selectivity optimization in liquid chromatography via stationary phase tuning

Selectivity optimization in liquid chromatography via stationary phase tuning

What is the role of current mass spectrometry in pharmaceutical analysis?

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