Manufacture of degarelix

A method for producing a degarelix drug substance comprising:

• a. purifying degarelix obtained by solid phase peptide synthesis to obtain a degarelix solution with a purity of at least 95%;
• b. concentrating the degarelix solution to obtain aggregated degarelix;
• c. deaggregating the aggregated degarelix with acetic acid to obtain deaggregated degarelix;
• and
• d. lyophilizing the deaggregated degarelix to provide the degarelix drug substance.

A method for producing a degarelix drug substance comprising:

• a. purifying degarelix to obtain a degarelix solution with a purity of at least 95%;
• b. loading the degarelix solution onto a chromatographic column;
• c. eluting degarelix from the column to provide eluted degarelix, wherein the acetic acid concentration is 27 to 37%;
• d. lyophilizing the eluted degarelix to provide the degarelix drug substance.

A method for producing a degarelix drug substance comprising:

• a. purifying degarelix to obtain a degarelix solution with a purity of at least 95%;
• b. adjusting an acetic acid concentration of the purified degarelix solution to 6 to 40% (w/w);
• and
• c. spray-drying the degarelix solution to provide the degarelix drug substance.