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US 2022/0413072 A1Published application
Nmr methods for antibody higher order structure comparability
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsIgor Dikiy, William Matousek
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Abstract
The present invention generally pertains to methods of characterizing antibody higher order structure. In particular, the present invention pertains to the use of novel NMR methods to compare manufacturing process variability in antibody higher order structure.
Claims33
A method for comparing manufacturing processes of at least one protein, comprising:
- a. obtaining a plurality of samples from at least two manufacturing processes;
- b. preparing said samples for NMR spectroscopy;
- c. subjecting prepared samples to a NMR experiment;
- d. obtaining NMR spectra for said samples from said NMR experiment;
- e. averaging said spectra of each of said at least two manufacturing processes;
- and
- f. comparing said averaged NMR spectra from said at least two manufacturing processes to detect differences in protein higher order structure.
4 more elements
A method for comparing manufacturing processes of at least one protein, comprising:
- (a) obtaining a plurality of protein samples from at least two manufacturing processes;
- (b) preparing said samples for NMR spectroscopy;
- (c) subjecting said samples to a NMR experiment;
- and
- (d) subjecting resulting NMR spectra to a principal component analysis to compare manufacturing processes to detect differences in protein higher order structure.
2 more elements
A method for characterizing a protein, comprising:
- a. obtaining a protein sample;
- b. preparing said sample for NMR spectroscopy;
- c. subjecting said sample to a NMR experiment;
- d. eliminating noise from empty areas of a resulting NMR spectrum;
- and
- e. analyzing the NMR spectrum to characterize the protein.
3 more elements
Dependencies are inferred from the claim text.