Investigation into Clearance of Organic Compounds from Biomanufacturing Process Streams during Ultrafiltration/Diafiltration

20260 citationsJournal Articlehybrid Open Access

Authors

Noemí Dorival-García · National Institute for Bioprocessing Research and Training

Anna Mulligan · University College Dublin

Ronan Hayes · Johnson & Johnson (United States)

Charles Felice · Johnson & Johnson (United States)

Aidan Sexton · Johnson & Johnson (United States)

Ping-Ping Wang · Johnson & Johnson (United States)

Jonathan Bones · University College Dublin

Abstract

The present work has created a strong background to describe the ability of UF/DF to remove potential organic leachables. Application of these modelling approaches becomes critical to support product safety assessments. Demonstration of significant removal along UF/DF operations confirms risk reduction of leachables coming mostly from upstream stages.

Topics & Keywords

Protein purification and stability Biosimilars and Bioanalytical Methods Viral Infectious Diseases and Gene Expression in Insects

Publication Details

Published in: Pharmaceutical Research

DOI: 10.1007/s11095-026-04050-2

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Investigation into Clearance of Organic Compounds from Biomanufacturing Process Streams during Ultrafiltration/Diafiltration

Authors

Abstract

Topics & Keywords

Publication Details