Superficially porous particles with 1000Å pores for large biomolecule high performance liquid chromatography and polymer size exclusion chromatography

Wagner, Brian M.; Schuster, Stephanie A.; Boyes, Barry E.; Shields, Taylor J.; Miles, William L.; Haynes, Mark J.; Moran, Robert E.; Kirkland, J. J.; Schure, Mark R.

doi:10.1016/j.chroma.2017.01.082

Cited by 61 publications

(44 citation statements)

References 28 publications

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“…Very recently SPPs have been successfully applied in SEC [95,96]. At first sight, the low pore volume of SPPs is thermodynamically disadvantageous, but the loss of pore volume can be compensated by shortening the diffusion length of the solutes inside the pores.…”

Section: Secmentioning

confidence: 99%

Current possibilities of liquid chromatography for the characterization of antibody-drug conjugates

Bobály

Fleury-Souverain²,

Beck

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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Antibody Drug Conjugates (ADCs) are innovative biopharmaceuticals gaining increasing attention over the last two decades. The concept of ADCs lead to new therapy approaches in numerous oncological indications as well in infectious diseases. Currently, around 60 CECs are in clinical trials indicating the expanding importance of this class of protein therapeutics. ADCs show unprecedented intrinsic heterogeneity and address new quality attributes which have to be assessed. Liquid chromatography is one of the most frequently used analytical method for the characterization of ADCs. This review summarizes recent results in the chromatographic characterization of ADCs and supposed to provide a general overview on the possibilities and limitations of current approaches for the evaluation of drug load distribution, determination of average drug to antibody ratio (DAR), and for the analysis of process/storage related impurities. Hydrophobic interaction chromatography (HIC), reversed phase liquid chromatography (RPLC), size exclusion chromatography (SEC) and multidimensional separations are discussed focusing on the analysis of marketed ADCs. Fundamentals and aspects of method development are illustrated with applications for each technique. Future perspectives in hydrophilic interaction chromatography (HILIC), HIC, SEC and ion exchange chromatography (IEX) are also discussed.

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Section: Secmentioning

confidence: 99%

Current possibilities of liquid chromatography for the characterization of antibody-drug conjugates

Bobály

Fleury-Souverain²,

Beck

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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“…The pore size distribution of the 160 Å SPPs was narrow and measured in-house. The 1000 Å SPPs have a have wider distribution and this is shown in a recent paper (26). The pore size distributions of the 200 Å and 1000 Å FPPs were not supplied by the manufacturer nor determined in-house.…”

Section: Experimental and Data Processing Conditionsmentioning

confidence: 52%

Size exclusion chromatography with superficially porous particles

Schure¹,

Moran

2017

Journal of Chromatography A

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A comparison is made using size-exclusion chromatography (SEC) of synthetic polymers between fully porous particles (FPPs) and superficially porous particles (SPPs) with similar particle diameters, pore sizes and equal flow rates. Polystyrene molecular weight standards with a mobile phase of tetrahydrofuran are utilized for all measurements conducted with standard HPLC equipment. Although it is traditionally thought that larger pore volume is thermodynamically advantageous in SEC for better separations, SPPs have kinetic advantages and these will be shown to compensate for the loss in pore volume compared to FPPs. The comparison metrics include the elution range (smaller with SPPs), the plate count (larger for SPPs), the rate production of theoretical plates (larger for SPPs) and the specific resolution (larger with FPPs). Advantages to using SPPs for SEC are discussed such that similar separations can be conducted faster using SPPs. SEC using SPPs offers similar peak capacities to that using FPPs but with faster operation. This also suggests that SEC conducted in the second dimension of a two-dimensional liquid chromatograph may benefit with reduced run time and with equivalently reduced peak width making SPPs advantageous for sampling the first dimension by the second dimension separator. Additional advantages are discussed for biomolecules along with a discussion of optimization criteria for size-based separations.

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“…In the recent development of particle technology targeted for liquid chromatography (LC), the use of superficially porous (SPP or often called as shell, core-shell, fused-core or partially-5 300-400 Å SPPs [26]. Very recently, another wide-pore silica-based SPP with a high coverage phenyl bonding has been released and successfully applied for the analysis of mAbs and antibody-drug conjugates (ADCs) [27].…”

Section: History Of Columns Packed With Spp Particlesmentioning

confidence: 99%

New developments and possibilities of wide-pore superficially porous particle technology applied for the liquid chromatographic analysis of therapeutic proteins

Bobály

Veuthey

Guillarme

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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This review paper discusses the success of columns packed with superficially porous particles (SPP) in liquid chromatography for the analysis of peptides and proteins. First, it summarizes the history of SPP, including the development of different SPP generations from particles of 50 μm to sub-2 μm. It also critically discusses the improved kinetic performance of SPP particles in comparison to fully porous particles. The current trends and applications of columns packed with SPPs for the analysis of peptides and proteins (including mAbs and ADC at the intact and sub-unit levels) are shown, as well. Finally, some of the potential perspectives for this technology are also described, including the radially oriented mesopores or the applicability of the technology for chiral separations.

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Superficially porous particles with 1000Å pores for large biomolecule high performance liquid chromatography and polymer size exclusion chromatography

Cited by 61 publications

References 28 publications

Current possibilities of liquid chromatography for the characterization of antibody-drug conjugates

Current possibilities of liquid chromatography for the characterization of antibody-drug conjugates

Size exclusion chromatography with superficially porous particles

New developments and possibilities of wide-pore superficially porous particle technology applied for the liquid chromatographic analysis of therapeutic proteins

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