Literature

So far, more than 260 peer reviewed papers have been published on the application of DryLab – a complete list of which you can find here.

DryLab draws on the philosophy described in the three most famous Solvophobic Theory papers IIIIII of Csaba Horváth, which were developed in the years 1975-1977 at Yale University (see also literature by Dr. Imre Molnár).

Read more about the Fundamentals of DryLab and its History.

Keyword Year

Structure-Function Assessment and High-Throughput Quantification of Site-Specific Aspartate Isomerization in Monoclonal Antibody Using a Novel Analytical Tool Kit

Kaimeng Zhou et al.
Journal of Pharmaceutical Sciences, 109, 1, 422-428 (2020)

Keywords: antibody, proteins, formulation, post-translational modification, isomerization, succinimide, liquid chromatography, peptide mapping, stability, structure-activity relationship

PDF
http://doi.org/10.1016/j.xphs.2019.08.018

Isomerization of surface-exposed aspartic acid (Asp) in the complementarity-determining regions of therapeutic proteins could potentially impact their target binding affinity because of the sensitive location, and often requires complex analytical tactics to understand its effect on structure-function and stability. Inaccurate quantitation of Asp-isomerized variants, especially the succinimide intermediate, presents major challenge in understanding Asp degradation kinetics, its stability, and consequently establishing a robust control strategy. As a practical solution to this problem, a comprehensive analytical tool kit has been developed, which provides a solution to fully characterize and accurately quantify the Asp-related product variants. The toolkit offers a combination of 2 steps, an ion-exchange chromatography method to separate and enrich the isomerized variants in the folded structure for structure-function evaluation and a novel focused peptide mapping method to quantify the individual complementarity-determining region isomerization components including the unmodified Asp, succinimide, and isoaspartate. This novel procedure allowed an accurate quantification of each Asp-related variant and a comprehensive assessment of the functional impact of Asp isomerization, which ultimately helped to establish an appropriate control strategy for this critical quality attribute.


A validated UHPLC-MS method for tryptophan metabolites: Application in the diagnosis of multiple sclerosis

Ferenc Tömösi et. al
J. Pharm. Biomed. Anal., 185, 1-12 (2020)

Keywords: Tryptophan metabolism, Derivatization, Liquid chromatography-mass spectrometry, DryLab®4, Validation, Multiple sclerosis

PDF
http://doi.org/10.1016/j.jpba.2020.113246

Highlights:

 

  • Simultaneous and robust quantification of tryptophan and its 11 metabolites.
  • Derivatization; separation of analytes on pentafluorophenyl column.
  • Optimization of chromatographic separation using DryLab®4 software.
  • Quantification of analytes in human cerebrospinal fluid and serum.
  • Reference study for the clinical and scientific research of multiple sclerosis.

 


Rapid analysis of polycyclic aromatic hydrocarbons

Justin M. Godinho, Jason Lawhorn, Barry E. Boyes
J. Chromatogr. A, 1628, 27 September, 1-14 (2020)

Keywords: Polycyclic aromatic hydrocarbons, PAH, HPLC, Fast LC, Superficially porous particles

PDF
http://doi.org/10.1016/j.chroma.2020.461432

Highlights:

    • New superficially porous material for analyzing polycyclic aromatic hydrocarbons.
    • In silico modeling aided development of material use conditions.
    • Comparison between superficially porous and fully porous materials.
    • Good resolution for robust sub-minute separation of 16-component mix.

 


Development of a design of experiments optimized method for quantification of polysorbate 80 based on oleic acid using UHPLC-MS

J. Puschmann, D.-H. Evers, C. C. Müller-Goymann, M. E. Herbig
J. Chromatogr. A, 1599, 136-143 (2019)

Keywords: Polysorbate 80, Design of experiments, Quantification, Oleic acid, UHPLC-MS Peak separation, Cis/trans separation

PDF
http://doi.org/10.1016/j.chroma.2019.04.015

Highlights:

  • Alternative to gas chromatographic methods for fatty acid identification developed.
  • DoE optimized methods for peak separation of fatty acids and 18:1 isomers.
  • The DoE software Drylab was used to calculate optimized and robust methods for peak separation with a full factorial design.
  • Separation of cis/trans and structural fatty acid isomers using derivatization.
  • Indirect polysorbate 80 quantification (0.05–5.83 μg/mL) achieved using oleic acid.

 


Tuning selectivity in cation-exchange chromatography applied for monoclonal antibody separations, part 1: Alternative mobile phases and fine tuning of the separation

E. Farsang et. al
J Pharm Biomed Anal., 168, 10 May, 138-147 (2019)

Keywords: Cation-exchange chromatography, pH gradient, Salt gradient, Salt-mediated pH gradient, Monoclonal antibody, Method development

PDF
http://doi.org/10.1016/j.jpba.2019.02.024

Highlights:

  • Alternative buffer systems are suggested for CEX separation of mAbs.
  • Benefits of salt mediated pH gradient are discussed.
  • The combination of a “true” pH- and salt gradients extends the possibilities of method development.
  • Retention modeling and method optimization were performed by DryLab®4
  • Complete method development is feasible within 6 h.

 


Is hydrophobic interaction chromatography the most suitable technique to characterize site-specific antibody-drug conjugates?

V. D’Atri, R. Pell, A. Clarke, D. Guillarme, Sz. Fekete
J. Chromatogr. A, 1586, 8 February, 149-153 (2019)

Keywords: Site-specific antibody drug conjugates, Hydrophobic interaction chromatography, Reversed phase liquid chromatography, Mass spectrometry, Biopharmaceuticals

PDF
http://doi.org/10.1016/j.chroma.2018.12.020

Highlights:

  • ADC consists of a recombinant mAb covalently linked to a cytotoxic molecule.
  • Hydrophobic interaction chromatography represents the gold standard for ADC analysis.
  • New site-specific ADC formats are more homogeneous than their previous generations.
  • RPLC is proposed as alternative method to HIC for site-specific ADC characterization.
  • Retention and resolution modeling was performed with DryLab®4 software.

 

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