Cell culture process for producing RSV F protein
Inventors
BREEN, Shelby Hutchins • HARRINGTON, Cameron Albert • JACOBS, Michaela Evelina • Lotvin, Jason Arnold • MULUKUTLA, Bhanu Chandra • Stead, David • SUMIT, Madhuresh
Assignees
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Publication Number
US-12734231-B2
Publication Date
2026-09-15
Expiration Date
Abstract
The invention relates to methods for producing an RSV F protein trimer in a fed batch cell culture.
Core Innovation
The invention describes a method for producing an RSV F protein trimer containing an engineered disulfide mutation using mammalian cells cultured across growth and production phases. Glucose is provided in a restricted, pH-responsive manner, designated as HiPDOG, wherein feeding responds to a rise in culture pH until returning to the culture set point. Operational details are omitted for safety: [procedural detail omitted for safety].
The disclosure reports increased trimer content, titer, and an improved impurity profile with restricted glucose feeding, identifying reduced cysteinylation as a product-quality outcome. Comparisons associate culture temperature shifts with lower host-cell protein, and the resulting RSV F trimers are designated for immunogenic compositions. Because background text is not provided, the specific problem addressed is not explicitly described in patent.
Claims Coverage
The claim coverage includes one independent claim reciting three inventive features concerning mammalian-cell production of an RSV F protein trimer, pH-responsive restricted glucose feeding, and an engineered disulfide mutation.
Mammalian-cell production of an RSV F protein trimer
Culturing mammalian cells containing a gene encoding RSV F protein through growth and production phases.
Restricted glucose feeding responsive to culture pH
Restricted glucose feeding provided in response to a rise in culture pH and continuing until pH returns to the set point during growth, production, or both phases. Further operational details are omitted for safety: [procedural detail omitted for safety].
Engineered disulfide mutation
The RSV F protein comprises an engineered disulfide mutation.
The independent claim covers mammalian-cell production of an RSV F protein trimer having an engineered disulfide mutation combined with pH-responsive restricted glucose feeding.
Stated Advantages
Restricted glucose feeding reduces RSV F protein cysteinylation compared with an otherwise similar method without restricted glucose feeding.
Documented Applications
Production of an RSV F protein trimer.
Use of the resulting RSV F trimers in immunogenic compositions.
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