Stable liquid pharmaceutical preparation
Inventors
Kim, So Young • SHIN, Yeon Kyeong • Kang, Hye Young • Kim, Kwang Woo • OH, Jun Seok • KIM, Su Jung • LEE, Joon Won • HAN, Won Yong • Lee, Jae bin • Roh, Ji Won • Kwak, Ji Min
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11730698-B2
Publication Date
2023-08-22
Expiration Date
Abstract
A stable liquid pharmaceutical formulation according to the present invention includes an antibody or antigen-binding fragment thereof, a surfactant, a sugar or a sugar derivative, a buffer, and a stabilizer. The stable liquid pharmaceutical formulation according to the present invention has low viscosity not only when antibody content is low but also when antibody content is high, and exhibits superior long-term storage stability based on superior stability observed under accelerated conditions and harsh conditions.
Core Innovation
The invention provides a stable liquid pharmaceutical formulation that comprises an antibody or antigen-binding fragment thereof, a surfactant, a sugar or a sugar derivative, a buffer, and a stabilizer. The antibody binds to HER2, the antibody concentration is 250 mg/ml or less, and the formulation does not comprise histidine.
The disclosed formulation is designed for stability as defined by multiple analytical acceptance criteria, with particular emphasis on maintaining low viscosity at both low and high antibody concentrations and preserving long-term storage stability under accelerated or harsh conditions. Stability is supported by measurements including turbidity, SEC-HPLC and CE-SDS variants, subvisible particles, and analysis of oxidation and charge variants.
The document further describes product and packaging concepts for delivering the stable liquid formulation, including pre-filled syringe or auto-injector formats and use of airtight containers, with avoidance of reconstitution or dilution before use. The formulation is applicable to intravenous administration and/or subcutaneous administration and includes disease treatment via HER2 binding.
Claims Coverage
The independent claim covers a stable liquid pharmaceutical formulation with one inventive feature set centered on a HER2-binding antibody or fragment and required formulation components, together with concentration and exclusion limits.
Stable liquid formulation with HER2-binding antibody or fragment plus required components
A stable liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof that binds to HER2, a surfactant, a sugar or a sugar derivative, a buffer, and a stabilizer; wherein the antibody concentration is 250 mg/ml or less and the stable liquid pharmaceutical formulation does not comprise histidine.
Overall claim coverage centers on a HER2-binding antibody formulation in stable liquid form through a defined combination of surfactant, sugar, buffer, and stabilizer, while limiting antibody concentration to 250 mg/ml or less and excluding histidine.
Stated Advantages
Low viscosity at both low and high antibody concentrations.
Superior long-term storage stability under accelerated or harsh conditions.
Documented Applications
Administering the stable liquid pharmaceutical formulation to a subject via intravenous or subcutaneous administration.
Disease treatment via HER2 binding using the stable liquid pharmaceutical formulation.
Interested in licensing this patent?