Protein-based therapeutics are produced in living cells, leading to inherent structural heterogeneity. Characterizing this heterogeneity is crucial for the successful development of therapeutic monoclonal antibodies. Post-translational modifications can influence in vivo stability, impair biological activity, and potentially trigger unwanted immune responses.
Aragen offers expert guidance and support to mitigate these risks by ensuring that protein structure and physicochemical analyses are conducted at the appropriate stages throughout therapeutic protein development. Our comprehensive and cutting-edge methods enable thorough characterization of protein structure, carbohydrate profiles, and post-translational modifications. This ensures compliance with ICH Q6B scientific guidelines, facilitating a more efficient and streamlined development process.
| Test Description | Our Solutions |
|---|---|
| Glycan Profiling |
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| Molecular weight Determination |
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| Peptide Mapping |
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| Disulfide Linkage Confirmation |
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