Immunogenic fusion protein compositions and methods of use thereof
AssigneeMatrivax, Inc.
InventorsEnda MORAN, Robert Thompson CARTEE, Kevin P. KILLEEN
Life of this patent
Estimating the term…
Abstract
The disclosure relates to immunogenic fusion protein compositions and methods of use thereof for preventing or treating pneumococcal infection. The disclosure relates to methods of producing and purifying immunogenic fusion proteins. This disclosure further relates to compositions and formulations comprising immunogenic fusion proteins.
Claims50
An immunogenic fusion protein comprising an amino acid sequence of SEQ ID NO:
- 43.
A composition comprising:
- i) a population of purified immunogenic fusion proteins, wherein at least about 90% of the purified immunogenic fusion proteins are full-length purified immunogenic fusion proteins comprising the amino acid sequence of SEQ ID NO:
- 43;
- ii) less than 80,000 ng of host cell protein/mg of purified immunogenic fusion protein;
- and/or
- iii) less than 17 EU of endotoxin/mg of purified immunogenic fusion protein.
A method of producing an immunogenic fusion protein, comprising the steps of:
- a) culturing a population of the host cells expressing an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43 in a condition suitable for the population of host cells to produce the immunogenic fusion protein;
- b) disrupting the cell membranes of the host cells;
- c) recovering a sample comprising the immunogenic fusion protein and one or more impurities;
- d) contacting the sample comprising the immunogenic fusion protein with a hydrophobic interaction chromatography resin and eluting the immunogenic fusion protein from the hydrophobic interaction chromatography resin under conditions that allow for preferential detachment of the immunogenic fusion protein, thereby obtaining an eluate comprising the immunogenic fusion protein;
- e) subjecting the eluate comprising the immunogenic fusion protein of step d) to a flow through anion exchange resin, thereby obtaining an eluate comprising the immunogenic fusion protein;
- and
- f) contacting the eluate comprising the immunogenic fusion protein of step e) with a multi-modal chromatography resin and eluting the immunogenic fusion protein from the multi-modal chromatography resin under conditions that allow for preferential detachment of the immunogenic fusion protein, thereby obtaining an eluate comprising the immunogenic fusion protein.
A formulation comprising:
- i) an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43;
- ii) a surfactant;
- iii) a buffer;
- and
- iv) a salt.
A formulation comprising:
- about 1.0 mg/mL of an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43, about 275 μg/mL polysorbate 20, about 10 mM sodium phosphate and about 154 mM sodium chloride, and wherein the pH level of the formulation is about 7.4.
A formulation comprising:
- about 20 μg/mL of an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43, about 275 μg/mL polysorbate 20, about 1 mg/mL of aluminum hydroxide in the formulation is about 7.4.
A formulation comprising:
- about 60 μg/mL of an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43, about 275 μg/mL polysorbate 20, about 1 mg/mL of aluminum hydroxide in 9 mM of sodium phosphate and about 139 mM sodium chloride, and wherein the pH level of the formulation is about 7.4.
A formulation comprising:
- about 120 μg/mL of an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43, about 275 μg/mL polysorbate 20, about 1 mg/mL of aluminum hydroxide in 9 mM of sodium phosphate and about 139 mM sodium chloride, and wherein the pH level of the formulation is about 7.4.
A formulation comprising:
- about 180 μg/mL of an immunogenic fusion protein comprising the amino acid sequence of SEQ ID NO:
- 43, about 275 μg/mL polysorbate 20, about 1 mg/mL of aluminum hydroxide in 9 mM of sodium phosphate and about 139 mM sodium chloride, and wherein the pH level of the formulation is about 7.4.
The method of claim 37, wherein the subject is administered with no more than two doses of the immunogenic fusion protein.
The method of any one of claim 48, wherein the parenteral administration is by intramuscular injection.
Dependencies are inferred from the claim text.