You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 6,685,940


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 6,685,940
Title: Protein formulation
Abstract:A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.
Inventor(s): Andya; James (Millbrae, CA), Cleland; Jeffrey L. (San Carlos, CA), Hsu; Chung C. (Los Altos Hills, CA), Lam; Xanthe M. (San Francisco, CA), Overcashier; David E. (El Granada, CA), Shire; Steven J. (Belmont, CA), Yang; Janet Yu-Feng (San Mateo, CA), Wu; Sylvia Sau-Yan (San Francisco, CA)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:09/809,511
Patent Claims:1. A formulation comprising a lyophilized mixture of a non-reducing sugar, a humanized antibody, and histidine, wherein the molar ratio of non-reducing sugar to humanized antibody is within the range from 100 to 600 mole non-reducing sugar:1 mole humanized antibody.

2. The formulation of claim 1 wherein the nonreducing sugar is trehalose or mannitol.

3. The formulation of claim 2 wherein the nonreducing sugar is mannitol.

4. The formulation of claim 3 wherein the molar ratio of mannitol to humanized antibody is within the range from 200 to 600 mole mannitol:1 mole humanized antibody.

5. The formulation of claim 3 further comprising glycine.

6. The formulation of claim 1 wherein less than about 10% of the humanized antibody is present as an aggregate in the formulation.

7. The formulation of claim 1 wherein increase in aggregated humanized antibody in the lyophilized formulation is less than about 5% when the lyophilized formulation is stored at 2-8.degree. C. for at least one year.

8. A reconstituted formulation comprising the formulation of claim 1 reconstituted in a diluent, wherein the humanized antibody concentration in the reconstituted formulation is within the range from 50 mg/mL to 400 mg/mL.

9. The reconstituted formulation of claim 8 wherein the humanized antibody concentration in the reconstituted formulation is within the range from 80 mg/mL to 300 mg/mL.

10. The reconstituted formulation of claim 8 wherein the diluent is sterile water, or bacteriostatic water for injection (BWFI).

11. The reconstituted formulation of claim 8 which is for subcutaneous or intramuscular administration.

12. The reconstituted formulation of claim 8 which is isotonic.

13. A sterile formulation comprising a lyophilized mixture of a non-reducing sugar and a humanized antibody, wherein the molar ratio of non-reducing sugar to humanized antibody is within the range from 200 to 600 mole non-reducing sugar:1 mole humanized antibody.

14. An article of manufacture comprising: (a) a container which holds the formulation of claim 13; and (b) instructions for reconstituting the lyophilized formulation with a diluent to a humanized antibody concentration in the reconstituted formulation within the range from 80 mg/mL to 300 mg/mL.

15. The article of manufacture of claim 14 further comprising a second container which holds the diluent, wherein the diluent is sterile water, or bacteriostatic water for injection (BWFI).

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.