Case Studies and Publications

Comparison of NIST mAb standard
with known variants

Secondary structure: are spectra
superimposable in far-UV?

Tertiary structure: are small
differences in near-UV significant?

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Differences in secondary structure not significant*
Differences in tertiary structure are significant*

* Tier 2 statistical analysis of data from Chirascan Q100 using 2SD acceptance criteria

Monitor change under stressed conditions
(forced degradation)

Analysis of tertiary structure. Spectra normalized for protein concentration by simultaneous absorbance measurements.
Chirascan™ Q100, n=6

Monitor change under stressed conditions (forced degradation)

High sensitivity CD analysis of IgG1 samples subjected to a range of degradation conditions revealed minor differences in tertiary structure when compared to a control sample.

Weighted spectral difference method: Dinh, Nikita et al. Anal. Biochem. 464 (2014): 60-62

Quantifiable assessment of changes in tertiary structure

Statistical analysis enabled objective confirmation of spectral results. Degradation conditions have affected local environment of aromatic side chains (no changes were detected in secondary structure – results not shown).

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Selected recent publications

Austerberry et al. 2017. “The Effect of Charge Mutations on the Stability and Aggregation of a Human Single Chain Fv Fragment.” European Journal of Pharmaceutics and Biopharmaceutics 115 (June): 18–30.

Bui and Nguyen. 2016. “Insights Into the Interaction of CD4 with Anti-CD4 Antibodies.” Immunobiology 222 (2): 148–54.

Moreno et al. 2016. “Study of Stability and Biophysical Characterization of Ranibizumab and Aflibercept.” European Journal of Pharmaceutics and Biopharmaceutics 108: 156–67.