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Generated: August 22, 2019

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Claims for Patent: 7,960,516

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Summary for Patent: 7,960,516
Title:Solid forms of anti-EGFR antibodies
Abstract: The invention relates to solid forms of antibodies against the EGF receptor, in particular precipitates and crystals of monoclonal antibodies against the EGF receptor, particularly preferably of Mab C225 (cetuximab) and Mab h425 (EMD 72000), which result in biologically active antibody protein through dissolution or suspension in aqueous medium, obtainable by precipitation of the antibody and/or one of its variants and/or fragments dissolved or suspended in aqueous medium by means of a precipitation reagent. The invention furthermore relates to pharmaceutical preparations comprising at least one solid form of above-mentioned antibodies in precipitated non-crystalline, precipitated crystalline or in soluble or suspended form, and optionally excipients and/or adjuvants and/or further pharmaceutical active ingredients, and to a process for the preparation of solid forms of anti-EGFR antibodies according to the invention.
Inventor(s): Matheus; Susanne (Neumagen-Dhron, DE), Mahler; Hanns-Christian (Wiesbaden, DE)
Assignee: Merck Patent GmbH (Darmstadt, DE)
Application Number:10/580,563
Patent Claims:1. A crystal of chimeric monoclonal antibody c225 (cetuximab) which remains a biologically active antibody protein when dissolved or suspended in an aqueous medium, said crystal being obtained by a process comprising incubating an aqueous solution or suspension of said c225 antibody with a precipitation reagent comprising ammonium sulfate, sodium acetate, sodium citrate, potassium phosphate, PEG and/or ethanol, for a time sufficient to allow formation of said crystal.

2. A process for the preparation of a crystal of chimeric monoclonal antibody c225 (cetuximab) which remains a biologically active antibody protein when dissolved or suspended in an aqueous medium, said process comprising incubating an aqueous solution or suspension of said c225 antibody with a precipitation reagent comprising ammonium sulfate, sodium acetate, sodium citrate, potassium phosphate, PEG and/or ethanol, for a time sufficient to allow formation of said crystal, and separating and isolating the crystal thereof.

3. A process according to claim 2, which is carried out in batch format.

4. A storage-stable medicament which comprises a crystal of claim 1 together with a stabilizing agent.

5. A pharmaceutical preparation which comprises a pharmaceutically acceptable carrier and the crystal according to claim 1, wherein said c225 antibody concentration is 50-150 mg/ml.

6. The crystal according to claim 1, which has a size of 50-200 .mu.m.

7. The crystal according to claim 1, wherein the precipitation reagent comprises saturated ammonium sulfate solution in 10 mM phosphate, pH 8.0.

8. The crystal according to claim 1, wherein the precipitation reagent comprises 50% (v/v) of ethanol in 10 mM citrate, pH 8.0.

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Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany103 55 904Nov 29, 2003
PCT Information
PCT FiledNovember 12, 2004PCT Application Number:PCT/EP2004/012837
PCT Publication Date:June 09, 2005PCT Publication Number:WO2005/051355

Details for Patent 7,960,516

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Imclone ERBITUX cetuximab VIAL; INTRAVENOUS 125084 001 2004-06-18 ➤ Sign Up Merck Patent GmbH (Darmstadt, DE) 2023-11-29 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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