Protein formulations and methods of making same
AssigneeAbbVie Inc.
InventorsWolfgang Fraunhofer, Annika Bartl, Hans-Juergen Krause, Markus Tschoepe, Katharina Kaleta
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Abstract
The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Claims18
An aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, a buffer, and water, wherein the formulation has a conductivity of less than about 2.5 mS/cm, and the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.
An aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, a buffer, and water, wherein the formulation has a conductivity of less than about 2.5 mS/cm,
- wherein the antibody, or antigen-binding fragment thereof, has a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:
- 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:
- 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8.
A method of preparing an aqueous formulation of an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer, the method comprising:
- a) providing the antibody, or antigen-binding fragment thereof, in a first solution;
- b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five-fold volume exchange with the water has been achieved to thereby prepare a diafiltered antibody solution;
- c) concentrating the diafiltered antibody solution and
- d) adding a non-ionizable excipient and a buffer to the concentrated diafiltered antibody solution, thereby preparing the aqueous formulation of the antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer
- wherein the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.
A method of preparing an aqueous formulation comprising an antibody, or antigen-binding fragment thereof, at a concentration of at least 50 mg/ml, a non-ionizable excipient, and a buffer and water, the method comprising:
- a) providing the antibody, or antigen-binding fragment thereof, in a first solution;
- b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five-fold volume exchange with the water has been achieved, to prepare a second solution;
- and
- c) adding a non-ionizable excipient and a buffer to the second solution, thereby preparing the aqueous formulation,
- wherein the antibody, or antigen-binding fragment thereof, has a molecular weight (Mw) greater than about 47 kDa.
Dependencies are inferred from the claim text.