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Last Updated: April 26, 2024

Claims for Patent: 9,610,301

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Summary for Patent: 9,610,301

Title:	Powdered protein compositions and methods of making same
Abstract:	A method for preparing a protein or peptide powder is provided that includes spray drying a solution including more than, e.g., about 50 mg/mL of a protein or peptide (e.g., an antibody or antigen binding portion thereof), and at least one excipient. Also provided are stable powdered compositions including a protein and an excipient having less than, e.g., about 6% residual moisture.
Inventor(s):	Lassner; Peter K. (Forcheim, DE), Adler; Michael (Freiburg, DE), Lee; Geoffrey (Erlangen, DE), Krause; Hans-Juergen (Gruenstadt, DE), Siedler; Michael (Munich, DE)
Assignee:	ABBVIE DEUTSCHLAND GMBH & CO KG (DE)
Application Number:	12/354,665
Patent Claims:	1. A pharmaceutical powder preparation comprising an effective amount of adalimumab and sodium hyaluronate, wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of adalimumab and an excipient which is either trehalose or sucrose, and wherein the pharmaceutical powder preparation has an excipient:adalimumab mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25.degree. C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40.degree. C. for three months. 2. A pharmaceutical powder preparation comprising an effective amount of adalimumab, wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of the adalimumab and an excipient which is either trehalose or sucrose, and wherein the pharmaceutical powder preparation has an excipient:adalimumab mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25.degree. C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40.degree. C. for three months. 3. A pharmaceutical powder preparation comprising an effective amount of a human anti-Tumor Necrosis factor alpha (TNF.alpha.) antibody and sodium hyaluronate, wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of antibody and an excipient which is either trehalose or sucrose, wherein the pharmaceutical powder preparation has an excipient:antibody mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25.degree. C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40.degree. C. for three months, and wherein the antibody comprises 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. 4. A pharmaceutical powder preparation comprising an effective amount of a human anti-Tumor Necrosis factor alpha (TNF.alpha.) antibody and sodium hyaluronate, wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of the antibody and an excipient which is either trehalose or sucrose, wherein the pharmaceutical powder preparation has an excipient:antibody mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25.degree. C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40.degree. C. for three months, and wherein the antibody comprises 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, comprises 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, and is an IgG. 5. A pharmaceutical powder preparation comprising an effective amount of a human anti-Tumor Necrosis factor alpha (TNF.alpha.) antibody and sodium hyaluronate, wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of the antibody and an excipient which is either trehalose or sucrose, wherein the pharmaceutical powder preparation has an excipient:antibody mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25.degree. C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40.degree. C. for three months, and wherein the antibody comprises an LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, and an HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2. 6. The pharmaceutical powder preparation of claim 3, wherein the antibody comprises an LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, an HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2, and is an IgG.

Details for Patent 9,610,301

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015	⤷ Try a Trial	2039-02-26
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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