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.
Claims22
An aqueous formulation comprising a protein and water, wherein the formulation has a conductivity of less than about 2.5 mS/cm and the protein has a molecular weight (Mw) greater than about 47 kDa.
An aqueous formulation comprising a protein at a concentration of at least about 10 ng/mL and water, wherein the formulation has a conductivity of less than about 2 mS/cm.
An aqueous formulation comprising a protein at a concentration of at least about 50 mg/mL and water wherein the formulation has an osmolality of no more than about 30 mOsmol/kg.
An aqueous formulation comprising water and a given concentration of a protein, wherein the protein has a hydrodynamic diameter (Dh) which is either at least about 50% less than the Dh of the protein in a buffered solution at the given concentration or the protein has a hydrodynamic diameter (Dh) of less than about 4 nm.
A method of preparing an aqueous formulation comprising a protein and water, the method comprising:
- a) providing the protein in a first solution;
- and
- 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 the aqueous formulation.
A method of preparing an aqueous formulation of a protein, the method comprising:
- a) providing the protein 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 protein solution;
- and
- c) concentrating the diafiltered protein solution to thereby prepare the aqueous formulation of the protein.
Dependencies are inferred from the claim text.