Formulations With Reduced Degradation of Polysorbate, Genentech
Summary
USPTO published patent application US20260108611A1 assigned to Genentech, Inc. on April 23, 2026, with a filing date of December 18, 2025. The application covers aqueous pharmaceutical formulations comprising a polypeptide, polysorbate, and cyclodextrin designed to reduce polysorbate degradation and decrease visible and sub-visible particle formation. Inventors are Brian ConnOLLY, Lydia Hamburg, and Emily Holz.
About this source
USPTO classification C07K covers peptides: short amino-acid chains that form the backbone of antibodies, hormones, vaccines, and increasingly a wider class of therapeutic modalities. Every newly published application in C07K lands in this feed, around 175 a month. Applications publish 18 months after filing, so this feed reveals what antibody engineering groups, vaccine developers, and plant biotech researchers were working on in the prior year and a half. Watch this if you compete in biologics, file freedom-to-operate analyses on antibody drug candidates, scout acquisition targets in vaccine platforms, or track protein-based agricultural biotech filings.
What changed
USPTO published patent application US20260108611A1 titled "Formulations with Reduced Degradation of Polysorbate" assigned to Genentech, Inc. The application discloses aqueous pharmaceutical formulations comprising a polypeptide, a polysorbate, and a cyclodextrin, along with methods for reducing polysorbate degradation and methods for reducing visible and sub-visible particles in such formulations. The formulations are classified under CPC codes A61K 47/40, A61K 9/0019, A61K 9/08, A61K 39/395, C07K 2317/31, and C07K 2317/55.
Pharmaceutical manufacturers developing biologic drug formulations containing polysorbate as a stabilizer should monitor this patent application for potential freedom-to-operate considerations. The use of cyclodextrin as a degradation-reducing agent in biologic formulations represents a specific technical approach that may inform formulation development strategies for protein-based therapeutics.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
FORMULATIONS WITH REDUCED DEGRADATION OF POLYSORBATE
Application US20260108611A1 Kind: A1 Apr 23, 2026
Assignee
Genentech, Inc.
Inventors
Brian CONNOLLY, Lydia HAMBURG, Emily HOLZ
Abstract
The invention provides methods for making such formulations and methods of using such formulations. The invention further provides methods of reducing polysorbate degradation, methods of reducing the amount of visible and sub-visible particles in an aqueous formulation, and methods of disaggregating polysorbate degradation products comprising adding a cyclodextrin to a formula comprising polysorbate and a polypeptide. The invention also provides aqueous formulations comprising a polypeptide, a polysorbate, and a cyclodextrin with reduced polysorbate degradation.
CPC Classifications
A61K 47/40 A61K 9/0019 A61K 9/08 A61K 39/395 A61K 39/39591 A61K 47/26 C07K 2317/31 C07K 2317/55
Filing Date
2025-12-18
Application No.
19425966
Parties
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