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US 10,011,637 B2Granted
Ultra-pure agonists of guanylate cyclase C, method of making and using same
AssigneeSynergy Pharmaceuticals, Inc.
InventorsKunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai Bai, Ruoping Zhang, Jun Jia, Junfeng Zhou, Qiao Zhao, Guoqing Zhang
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Abstract
The invention provides processes of purifying a peptide including a GCC agonist sequence selected from the group consisting of SEQ ID NOs: 1-251 described herein. The processes include a solvent exchange step before a freeze-drying (lyophilization) step.
Claims24
A purified peptide comprising the GCC agonist amino acid sequence of SEQ ID NO:
- 1, wherein the purified peptide has the following characteristics:
- a) has a bulk density of not greater than 0.1 g/mL;
- b) contains less than 50 ppm acetamide;
- c) less than 0.25% alpha-Asp-9-plecanatide (RRT 1.33) per total weight of peptide;
- and
- d) less than 0.05% trifluoroacetic acid (TFA) per total weight of peptide.
3 more elements
A process of purifying a peptide comprising the GCC agonist sequence selected from the group consisting of SEQ ID NOs:
- 1-54 and 56-251, the process comprising:
- providing a first peptide solution comprising a peptide comprising the GCC agonist sequence selected from the group consisting of SEQ ID NOs:
- 1-54 and 56-251, water, and acetonitrile;
- loading a C18 or polymeric adsorbent column with the first peptide solution to adsorb the peptide onto the C18 or polymeric adsorbent column,
- eluting the peptide off the C18 or polymeric adsorbent column with an alcohol aqueous solution to form a second peptide solution,
- reducing the amount of alcohol in the second peptide solution, and
- lyophilizing the second peptide solution such that a dry peptide is obtained.
4 more elements
Dependencies are inferred from the claim text.