Changeflow GovPing Pharma & Drug Safety Cell Culture Method Suppressing Foam Aggregates
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Cell Culture Method Suppressing Foam Aggregates

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Published November 28th, 2025
Detected March 26th, 2026
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Summary

The USPTO has published a new patent application (US20260085282A1) from FUJIFILM Corporation detailing a cell culture method. The method aims to suppress foam aggregate formation by adjusting poloxamer concentration or foam liquid viscosity during cell culture at high densities.

What changed

This document is a published patent application from FUJIFILM Corporation (Application No. 19403607, Publication No. US20260085282A1) filed on November 28, 2025. It describes a cell culture method designed to suppress foam aggregate formation. The method involves culturing cells at a density between 30 to 400 million cells/mL, either by controlling the poloxamer concentration in the foam liquid to be six times or less than that in the culture solution, or by adjusting the foam liquid's viscosity to 1.5 mPa·s or less under specific temperature conditions (35-38°C).

While this is a patent application and not a regulation imposing direct compliance obligations, it signals potential future technological advancements in biopharmaceutical manufacturing. Companies involved in cell culture and product manufacturing, particularly those using high cell densities, should be aware of this patented technology. Compliance officers in the pharmaceutical and biotechnology sectors may wish to monitor related developments and consider the implications for their own research, development, and manufacturing processes, especially concerning intellectual property and process optimization.

Source document (simplified)

← USPTO Patent Applications

CELL CULTURE METHOD AND PRODUCTION METHOD FOR PRODUCT

Application US20260085282A1 Kind: A1 Mar 26, 2026

Assignee

FUJIFILM Corporation

Inventors

Atsushi INADA, Shinichi NAKAI, Katsuhiro SHIMONO

Abstract

An object of the present invention is to provide a cell culture method and a production method for a product, in which an occurrence of aggregates in foam is suppressed. According to the present invention, there is provided a cell culture method of culturing cells at a cell density of 30×106 cells/mL or more and 400×106 cells/mL or less in a culture solution, the method including: step A of adjusting a poloxamer concentration in a foam liquid constituting foam to be 6 times or less a poloxamer concentration in the culture solution; or step B of adjusting a viscosity of the foam liquid constituting the foam to be 1.5 mPa·s or less under conditions of 35° C. or higher and 38° C. or lower.

CPC Classifications

C12N 5/0018 C07K 16/00 C12N 2500/50

Filing Date

2025-11-28

Application No.

19403607

View original document →

Classification

Agency
USPTO
Published
November 28th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
US20260085282A1

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing 3254.1 Biotechnology
Activity scope
Cell Culture Biopharmaceutical Production
Threshold
cell density of 30×106 cells/mL or more and 400×106 cells/mL or less
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Research & Development
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Biotechnology Manufacturing Processes

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