Qualitative analysis of proteins
A qualitative, protein-based technique used in the characterization and analysis of proteins
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Embodiment 1
[0114] Example 1. Protein Analysis - Example Workflow for Biologics Characterization
[0115] 1. Purification of Proteins by Affinity Chromatography
[0116] 2. Buffer Exchange by Gel Filtration
[0117] 3. Optionally denature, reduce, alkylate, then dilute
[0118] 4. Protease digestion by solid-phase enzymes followed by dilution
[0119] 5. Desalting with Ion-Pair Reverse Phase
[0120] 6. Chromatography-mass spectrometry analysis
[0121] Protein drugs and protein drug candidates differ from conventional small molecule drugs in that they are not chemically synthesized. In contrast, protein drugs called biologics are recombinant proteins synthesized using the cellular machinery of living mammalian cells.
[0122] Therefore, a major challenge in manufacturing biologics is maintaining post-translational modifications, protein molecular weight, charge homogeneity, and other physical attributes. In summary, these analytical measurements require high-performance, low-volu...
Embodiment 2
[0124] Example 2. Example Workflow for Protein Complex Disease Marker Discovery and Diagnostics
[0125] 1. Add His-tag recombinant protein to the sample
[0126] 2. Swap native protein with tagged recombinant protein
[0127] 3. Purification of Proteins by Affinity Chromatography
[0128] 4. Buffer Exchange by Gel Filtration
[0129] 5. Optionally denature, reduce, alkylate, then dilute
[0130] 6. Protease digestion by solid phase enzyme followed by dilution
[0131] 7. Desalting with Ion-Pair Reverse Phase
[0132] 8. Chromatography-mass spectrometry analysis
[0133] In the case of functional cells, proteins rarely act as individual proteins. Instead, proteins associate with many different proteins and form protein complexes. Sometimes these complexes are transient interactions and can be difficult to detect. Protein complexes are a viable source of disease information, and components of protein complexes are potential disease markers. Recent advances in the fie...
Embodiment 3
[0136] Example 3. Example Workflow for Peptide Mapping Analysis
[0137] 1. Provide samples
[0138] 2. Buffer Exchange by Gel Filtration
[0139] 3. Denaturation, reduction, alkylation
[0140] 4. Dilute with buffer
[0141] 5. Protease digestion by solid-phase trypsin, Glu-C, Lys-N, Lys-C, Asp-N, Arg-C and / or chymotrypsin digestion enzymes
[0142] 6. Dilution
[0143] 7. Add ion-pair reagent and desalt with ion-pair reverse phase
[0144] 8. Chromatography-mass spectrometry analysis
[0145] Discover protein drug candidates by screening libraries against druggable targets. Once positive interactions are found, drug candidates are optimized in terms of their binding effects. The process first requires the identification of specific peptides on the target to which the drug candidate binds, a process known as epitope mapping. A major challenge in epitope mapping is to generate robust, reproducible, and complete methods.
[0146] Drug targets are recombinant proteins...
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