- Assignee: Amgen Inc.
- Patent Number: 12,351,613 B2
- Filing Date: August 31, 2022
- Patent Issued: July 8, 2025
- Inventors: Christopher Kenyon Crowell & Gustavo Enrique Grampp
- Field: Biotechnology / Biomanufacturing
What This Patent Covers
This patent describes methods, culture media, and processes for producing glycoproteins with improved glycosylation and sialylation profiles by using manganese supplementation in cell culture systems. Glycoproteins are proteins with sugar (carbohydrate) chains attached — and their sugar patterns critically affect therapeutic protein efficacy, half-life, stability, and immunogenicity.
Core Innovations
- Manganese-supplemented culture media:
The invention claims compositions of cell culture media that include manganese in effective amounts to enhance the glycosylation profile of expressed proteins. Proper glycosylation — especially sialylation (addition of terminal sialic acids) — is essential for the clinical performance of many biologic drugs. - Methods of growing host cells:
It lays out specific culture conditions for mammalian host cells engineered to produce therapeutic glycoproteins (such as antibodies, erythropoietin, and other complex proteins) that, when grown in the manganese-augmented media, yield higher quality glycoproteins. - Applicability across biologics:
While early priority applications date back years, the granted patent extends rights, covering manganese-enhanced glycoprotein production broadly — a foundational manufacturing improvement for recombinant biologics.
Why It’s Important
1. Improves Therapeutic Protein Quality
Amgen makes numerous glycoprotein therapeutics — including monoclonal antibodies and hormones — where proper glycosylation can influence drug half-life, receptor interaction, immune effector functions, and safety profiles. Controlling glycosylation via media composition offers concrete clinical and commercial advantages.
2. Biomanufacturing Competitive Edge
Manufacturing biologics with consistent, well-defined glycosylation is a perennial industry challenge. This patent protects a manufacturing optimization that can reduce batch variability, improve yields, and support premium pricing or regulatory advantage for Amgen’s products.
3. Broad Platform Value
Rather than tying to a single drug, this patent’s claims span culture methods and media improvements across many glycoprotein products, potentially impacting a large part of Amgen’s biologics portfolio — a significant revenue source.
4. Extended Protection of Established Know-How
Although the core invention traces to older provisional filings (dating back many years), the grant extends and reinforces Amgen’s intellectual property coverage on key manufacturing know-how into the next decade, crucial as biosimilar competition increases around blockbusters like denosumab/prolia/Xgeva.
Summary
U.S. Patent No. 12,351,613 B2, issued to Amgen Inc. in July 2025, covers enhanced methods and media compositions using manganese to produce glycoproteins with improved quality characteristics. Because glycosylation directly impacts the performance and market value of many biologics, this patent represents a strategic manufacturing technology that supports Amgen’s biologics portfolio and competitive positioning in the biopharmaceutical industry.
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