Rapid deamidation screening
AssigneeProtein Dynamic Solutions, Inc.
InventorBelinda PASTRANA-RIOS
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Abstract
Rapid comparability assessment of asparagine or glutamine deamidation of therapeutic proteins, peptides other modalities against a reference standard using two trace two-dimensional correlation spectroscopy. Asynchronous plots are generated providing information of the abundance of the components under evaluation. The method is valid for an array of protein samples providing an estimate of the extent of deamidation. The results of which are orthogonal to HPLC cation exchange, thus validating the existence of the deamidated species and if aggregate is present. This rapid method run time is only 10 minutes for up to 21 samples in their formulation condition.
Claims5
A method for deamidation screening of a sample comprising:
- a) providing the sample in a slide containing at least one sample well and at least one reference well;
- b) acquiring at least one spectral image of the sample and at least one spectral image of the reference using a quantum cascade laser microscope under a controlled temperature condition;
- c) identifying and selecting, in at least one of the acquired spectral images of the sample and the reference, a region of interest;
- d) obtaining spectral data for the sample for the sample region of interest and obtaining spectral data of the reference for the reference region of interest;
- e) applying a baseline correction to the spectral data for the sample and the reference for the region of interest;
- f) applying a two-trace two-dimensional correlation to the baseline corrected sample and reference spectral data to generate a synchronous spectrum Φ(v1, v2) and Asynchronous Spectrum Ψ(v1, v2);
- generating a synchronous plot and an asynchronous plot from the synchronous and asynchronous spectra;
- and
- analyzing signature peaks to determine an estimation of deamidation of the sample.
Dependencies are inferred from the claim text.