EPO Patent EP4671270A3: Purifying Low-pI Antibody
Summary
The European Patent Office has published patent application EP4671270A3 concerning a method for purifying antibodies with a low isoelectric point. The patent describes techniques to suppress aggregation and improve impurity removal during antibody purification processes.
What changed
This document is a European Patent Office (EPO) publication (EP4671270A3) detailing a method for purifying antibodies with a low isoelectric point. The patent claims an improved purification process that involves removing formed antibody aggregates after Protein A column purification, acidic treatment, and neutralization to suppress further aggregation. It also specifies the use of an anion exchange resin in Bind/Elute mode followed by hydrophobic interaction chromatography or multimodal chromatography for efficient impurity removal, contrasting with conventional methods.
This patent publication is primarily of interest to pharmaceutical and biotechnology companies involved in antibody development and manufacturing. While it does not impose new regulatory obligations, it represents a novel technical approach that may influence future manufacturing processes and intellectual property strategies within the industry. Compliance officers should note this development for its potential impact on R&D and manufacturing best practices.
Source document (simplified)
METHOD FOR PURIFYING ANTIBODY HAVING LOW ISOELECTRIC POINT
Search Report EP4671270A3 Kind: A3 Mar 18, 2026
Applicants
CHUGAI SEIYAKU KABUSHIKI KAISHA
Inventors
UEDA, Yasufumi, KOBAYASHI, Shohei, YANAGITA, Satoko, KAWASE, Takuo, FUKUNAGA, Masahiro
Abstract
The present inventors discovered that additional aggregation of low-pI antibody can be suppressed by removing formed antibody aggregates after a certain period of time following Protein A column purification, acidic treatment, and neutralization. Furthermore, the present inventors found that efficient impurities removal for a low-pI antibody can be accomplished by using an anion exchange resin in the Bind/Elute mode and then a hydrophobic interaction chromatography or multimodal chromatography resin, compared with conventional methods.
IPC Classifications
C07K 1/22 20060101AFI20260210BHEP A61K 39/395 20060101ALI20260210BHEP C07K 1/18 20060101ALI20260210BHEP C07K 1/20 20060101ALI20260210BHEP C07K 16/00 20060101ALI20260210BHEP
Designated States
AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR
Named provisions
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when ChangeBridge: EPO Bulletin - Peptides (C07K) publishes new changes.