Stabilized protein crystals formulations containing them and methods of making them

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is an oxidase enzyme;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation has at least a 59 fold greater shelf life when stored at 40° C. and 75% humidity than a nonformulated form of said protein crystal when stored at 40° C. and 75% humidity, as measured by the time required for the specific activity of the protein to decrease by 50% (T½).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is human Serum albumin;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation has at least a 59 fold greater shelf life when stored at 40° C. and 75% humidity than a nonformulated form of said protein crystal when stored at 40° C. and 75% humidity, as measured by the time required for the specific activity of the protein to decrease by 50% (T½).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is selected from the group consisting of hydrolases, lipases, bacterial proteins and human growth hormone;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.9 and 30:70 (W/W);
• wherein said formulation has at least a 60% greater shelf life when stored at 50° C. than a nonformulated form of said protein crystal when stored at 50° C., as measured by the time required for the specific activity of the protein to decrease by 50% (T½).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is an oxidase enzyme;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:9.99 and 30:70 (W/W);
• wherein said formulation has at least a 60% greater shelf life when stored at 50° C. than a nonformulated form of said protein crystal when stored at 50° C., as measured by the time required for the specific activity of the protein to decrease by 50% (T½).

A formulation comprising:

• a) a batch-processed protein Crystal, wherein said protein is human serum albumin;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation has at least a 60% greater shelf life when stored at 50° C. than a nonformulated form of said protein crystal when stored at 50° C., as measured by the time required for the specific activity of the protein to decrease by 50% (T½).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is selected from the group consisting of hydrolases, lipases, bacterial proteins and human growth hormone;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation loses less than 20% α-helical structural content of the protein after storage for 4 days at 50° C., wherein a soluble form of said protein loses more than 50% of its α-helical structural content after storage for 6 hours at 50° C., as measured by fourier transform infrared (FTIR).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is an oxidase enzyme;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation loses less than 20% α-helical structural content of the protein after storage for 4 days at 50° C., wherein a soluble form of said protein loses more than 50% of its α-helical structural content after storage for 6 hours at 50° C., as measured by fourier transform infrared (FTIR).

A formulation comprising:

• a) a batch-processed protein crystal, wherein said protein is human serum albumin;
• and
• b) an excipient, wherein said excipient and said protein crystal are in a ratio between 0.01:99.99 and 30:70 (W/W);
• wherein said formulation loses less than 20% α-helical structural content of the protein after storage for 4 days at 50° C., wherein a soluble form of said protein loses more than 50% of its α-helical structural content after storage for 6 hours at 50° C., as measured by fourier transform infrared (FTIR).