Stabilisierte Antikörperhaltige Flüssige Formulierungen

EP4755374 10. Juni 2026

Anmelder: CHUGAI SEIYAKU KABUSHIKI KAISHA 🇯🇵

Details

Veröffentlichungs-Nr.
EP4755374
Anmeldetag
20. Januar 2011
Veröffentlichung
10. Juni 2026
Rechtsraum
EP
Offizieller Volltext

Abstract

An objective of the present invention is to provide stable antibody-containing formulations which are suitable for subcutaneous administration and in which aggregation formation is suppressed during long-term storage.The present inventors discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer. The present inventors also discovered that a significant stabilization effect was achieved by using an acidic amino acid, aspartic acid or glutamic acid, as a counter ion species to a basic amino acid such as arginine, specifically by using arginine-aspartate or arginine-glutamate.

Anmelder

Firma
CHUGAI SEIYAKU KABUSHIKI KAISHA
Land
🇯🇵 Japan
🇯🇵 Chugai Pharmaceutical

Chugai Pharmaceutical Co., Ltd. ist ein japanisches Pharmaunternehmen mit Sitz in Tokio, das insbesondere Biopharmazeutika entwickelt und mehrheitlich zur Roche-Gruppe gehört.

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