Title:
High concentration monoclonal antibody tablet
Document Type and Number:
Japanese Patent JP6254581
Kind Code:
B2
Abstract:
The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscocity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.
Inventors:
Armstrong, Nicholas J.
Bowen, Mayumi N.
Mar, Yu-fan
Bowen, Mayumi N.
Mar, Yu-fan
Application Number:
JP2015512877A
Publication Date:
December 27, 2017
Filing Date:
May 17, 2013
Export Citation:
Assignee:
Genentech, Incorporated
International Classes:
A61K39/395; A61K9/10; A61K47/10; A61K47/14; A61K47/26
Domestic Patent References:
| JP2007537283A | ||||
| JP2010530852A |
Foreign References:
| US20110223208 |
Other References:
BIO INDUSTRY,2010年,Vol.27, No.7,p.18-23
Attorney, Agent or Firm:
Sonoda Yoshitaka
Kobayashi Yoshinori
Kobayashi Yoshinori