RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS

1 . A method of determining the stability increase provided by a non-reducing sugar in a pharmaceutical composition containing a protein therapeutic, the method comprising:

(i) providing:

a first pharmaceutical composition comprising an aqueous solution of the protein therapeutic in the substantial absence of a non-reducing sugar, wherein the first pharmaceutical composition has a first B 22 value and

a second pharmaceutical composition comprising an aqueous solution of the protein therapeutic and the non-reducing sugar, wherein the second pharmaceutical composition has a second B 22 value;

(ii) determining the difference between the first and second B 22 values; and

(iii) predicting the stability increase provided by the non-reducing sugar based on the difference in B 22 values.

2 . The method of claim 1 , wherein, in step (ii) determining the difference between the first and second B 22 values comprises measuring the first and second B 22 values using static light scattering.

3 . The method of claim 1 , wherein, in step (ii) determining the difference between the first and second B 22 values comprises measuring the first and second B 22 values using dynamic light scattering.

4 . The method of claim 1 , wherein the first and second pharmaceutical compositions comprise at least one additional excipient which is a buffer, an isotonic agent or a surfactant.

5 . The method of claim 4 , wherein the additional excipient is the isotonic agent.

6 . The method of claim 5 , wherein the isotonic agent is NaCl.

7 . The method of claim 1 , wherein the non-reducing sugar is sucrose, trehalose, raffinose, or a combination thereof.

8 . The method of claim 1 , wherein the protein therapeutic agent is an antibody or a combination of antibodies.